Who is the manufacturer of ELAN 4 Motor System?

Aesculap, Inc. filed the 510(k) submission for ELAN 4 Motor System (K152960).

What is the FDA product code for ELAN 4 Motor System?

HBC. It is classified under 21 CFR 882.4360 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ELAN 4 Motor System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ELAN 4 Motor System?

Microspeed Uni Motor System (K053526).

Who can help prepare an FDA 510(k) submission like ELAN 4 Motor System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELAN 4 Motor System

K152960 · Aesculap, Inc. · HBC · Jul 22, 2016 · Neurology

Device Facts

Record ID	K152960
Device Name	ELAN 4 Motor System
Applicant	Aesculap, Inc.
Product Code	HBC · Neurology
Decision Date	Jul 22, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4360
Device Class	Class 2
Attributes	Therapeutic

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 Story

ELAN 4 Electro Motor System is an electrical motor system for bone dissection; consists of a control unit, various handpieces with integrated motors, and attachments (burrs, saw blades, drills). System operates at high speeds up to 80,000 RPM and low speeds between 1,000 and 20,000 RPM. Operated by surgeons in clinical settings; system settings managed via touch screen on control unit; handpiece functions controlled via foot switch in sterile field. Features include distal tool adaptation and burr release mechanism (only in off position) to improve performance and safety. System provides irrigation pump. Benefits include precise bone cutting/drilling/sawing; improved safety via secure tool locking and temperature management. Device is intended for use by trained medical professionals.

Clinical Evidence

Bench testing only. Testing included 100-123 cycles of use per handpiece type (drill, craniotome, perforator, reciprocating saw, sagittal saw) to evaluate functional performance, safety, and reprocessing durability (cleaning, disinfection, steam sterilization). Metrics included tool coupling/uncoupling, motor cable integrity, temperature monitoring, and mechanical/electrical failure rates. All tests passed, demonstrating equivalent or improved performance compared to the predicate.

Technological Characteristics

System includes control unit with touch screen and handpieces with integrated motors. Materials: stainless steel, PEEK. Power: 100-240V, 50-60Hz. Connectivity: foot switch control. Standards: UL 2601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304. Sterilization: steam sterilization. Software: IEC 62304 compliant.

Indications for Use

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

Regulatory Classification

Identification

An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

Microspeed Uni Motor System (K053526)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 22, 2016 Aesculap, Inc. Mr. Peter Stoll Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034 Re: K152960 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: June 3, 2016 Received: June 23, 2016 Dear Mr. Stoll: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Carlos L. Pena -S 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) K152960 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) | |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over The Counter Use (21 CFR 801 Subpart C) | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ ## 510(k) SUMMARY (as required by 21 CFR 807.92) ELAN 4 Greet q'Motor System July 21, 2016 | COMPANY: | Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 | |-----------------------|--------------------------------------------------------------------------------------------------------------------| | CONTACT: | Peter Stoll 610-984-9076 (phone) 610-791-6882 (fax) | | TRADENAME: | ELAN 4 Electro Motor System | | COMMON NAME: | Drills, Burrs, Trephines & Accessories (Simple, Powered) | | CLASSIFICATION NAME: | Powered simple cranial drills, burrs, trephines and their accessories | | CLASSIFICATION PANEL: | Neurology | | REGULATION NUMBER: | 21 CFR 882.4310 | PRODUCT CODE: HBE ### SUBSTANTIAL EQUIVALENCE The ELAN 4 Electro Motor System is substantially equivalent to Aesculap's Microspeed Uni Motor System cleared via K053526. ### DEVICE DESCRIPTION The ELAN 4 Electro motor system is an electrical motor system consisting of a control unit with different sizes and types of handpieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc. 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. System settings are controlled with the touch screen panel of the control unit, while all functions of the handpieces can be controlled from the sterile field by the foot control. ### 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. ### TECHNOLOGICAL CHARACTERISTICS (compared to predicates) The modifications made to the ELAN 4 Electro motor system do not affect the fundamental scientific technology. The design, materials, and principal of operation have not changed for these devices. The ELAN 4 Electro Motor System offers similar operating speeds, power sources, and attachments as the predicate device. A table of the modifications between the predicate and the ELAN 4 Electro is below. The performance of the device was determined to be equivalent or improved for the device, in comparison to the predicate, due to each of the changes. Material changes such as changing to stainless steel or another type of PEEK were evaluated and determined to {4}------------------------------------------------ present no new risk to patients. Additionally, new features such as the distal tool adaptation and burr release mechanism were determined to present no new risk to patient and improved the performance of the device by reducing temperature and ensuring burrs do not release during use. This comparison supports the claim of substantial equivalence to the predicate device for the proposed intended use. | Device Modification | Risk | Verification Activity | Acceptance Criteria | Results of Verification | |--------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------| | handpieces (GA) | | | | | | material change from titinium alloy to stainless steel | No new risk to patient. | Verification testing and biocompatibility testing per ISO 10993-1 | Engineering specification | Pass. Does not raise new questions of safety and effectiveness. | | material change from PEEK (blue) to PEEK (black) | No new risk to patient. | Verification testing (also see Appendix A below) | Engineering specification | Pass. Does not raise new questions of safety and effectiveness. | | motor and handpiece has no coupling (one piece) | no new risk to patient | Verification testing (also see Appendix A below) | Engineering specification | Pass. Does not raise new questions of safety and effectiveness. | | tool adaption at distal end of handpiece | no new risk to patient | Verification testing (also see Appendix A below) | Engineering specification | Pass. Does not raise new questions of safety and effectiveness. | | burr release only in off position mechanism | no new risk to patient | Verification testing (also see Appendix A below) | Engineering specification | Pass. Does not raise new questions of safety and effectiveness. | ### Comparison To Predicate | System | Elan 4 Electro (subject of this submission) | Microspeed Uni | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K# | 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. | Aesculap's 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 | | 2 of 11 | | Maximum | 80,000 rpm | 80,000 rpm | {5}------------------------------------------------ | speed | | | |------------------------------------------------|----------------------------------------------------|----------------------------------------| | Voltage | 100-240 V | 100 - 240V | | Frequency | 50-60Hz | 50 - 60Hz | | Irrigation Pump | Yes | Yes | | Motor | | | | High speed motor Min/Max | 10,000/ 80,000 rpm | 5,000 rpm / 80,000 rpm | | Low speed motor Min/Max | 1,000/ 20,000 rpm | 3,000 rpm / 40,000 rpm | | Motor rotation High speed | Left and right hand rotation | Left and right hand rotation | | Low speed | Left and right hand rotation | Left and right hand rotation | | Materials | Stainless Steel | Titanium Alloy | | Features | | | | Control mechanism | Foot | Hand and foot | | Ability to connect various Handpieces | Yes | Yes | | Motor connections | 2 | 2 | | Footswitch connections | 1 | 1 | | Control Unit | Touch screen | Touch screen | | Applied standards | UL2601-1 IEC60601-1 IEC60601-1-2 IEC62304 | UL2601-1 IEC60601-1 IEC60601-1-2 | #### PERFORMANCE DATA ELAN 4 Electro Motor System has been tested in accordance with FDA recognized standards IEC 60601-1, IEC 60601-1-2, IEC 62304, and UL 2601-1. Bench testing was performed with each handpiece to demonstrate equivalent or improved performance in comparison to the predicate device. Bench testing summaries are below. Each handpiece demonstrated equivalent or improved performance compared to the acceptance criteria. ## Bench Testing of ELAN 4 Attachments ## Elan 4 Bench Testing Handpieces Summary Table | Requirement | Acceptance | Sample | Results | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | contour milling could be performed without affecting the test pattern itself. | as representative of the standard tool portfolio "XS" is per application and processing cycle with the test pattern to be milled {Drill hand pieces GA861 and GA864} in bone replacement material {ash hardwood}. Definition of the tools used, | 120 cycles | The 120 application cycles, i.e. "a" contour milling could be performed without affecting by the test pattern itself Pass | | Coupling Toolfunctions | Tool is manually decouple d {with actuator) | 120 times | 120 times "OK", ie at 120 cycles of use, the tool was automatically coupled and uncoupled manually. There were no problems with tool coupling. PASS | | Determining the weight before the RDG / after the RDG / after the oiling / after the Sterilization has shown that the weight remained constant before and just after the entire processing cycle. | No impairment of function and safety by cleaning, Disinfection and steam sterilization | 120 cycles | During the preparation and application of 120 cycles, there were no function and safety impairments caused by cleaning, disinfection and steam sterilization. PASS | | To evaluate the acceptance criteria, all analysis of all of the other 20 acceptance criteria can be used. Since all other 20 acceptance criteria were "satisfied" rated, this also applies to requirement (5). After and during 120 application and processing cycles, there was no functional and safety impairments. | No impairment of function and safety during and after at least 100 applications and processing cycles | 120 cycles | Since all other acceptance criteria were satisfied this requirement can be determined to have met acceptance criteria. PASS | | After 120th processing and application cycles all relevant information (manufacturer, part number, serial number) the labels are still identifiable / readable. | Labels are still readable after min.100 application and processing cycles | 120 cycles | After 120 cycles all relevant information are still identifiable/readable. PASS | | 120 times "OK", at 120 cycles of use, the motor cables could be easily coupled and uncoupled. | Motor cable can be coupled and uncoupled | 120 cycles | After 120 cycles the motor cables could be easily coupled/uncoupled. PASS | | 120 times "no", ie at 120 cycles of use, there was no interruption of operation through the cable | No interruption of operation by releasing the cable | 120 cycles | After 120 cycles there was no interruption of operation through the cable. PASS | | 120 times "no", at 120 cycles of use, there was no operation interruption due to failure of electrical components | interruption of operation due to failure of electrical components | 120 cycles | After 120 cycles no operation interruption due to failure of electrical components. PASS | | 120 times "no", ie at 120 cycles of use, there was no interruption due to failure of mechanical components. | No interruption of operation due to failure of mechanical components | 120 cycles | After 120 cycles no operation interruption due to failure of mechanical components. PASS | | 120 times "no", at 120 cycles of use the tool during application was securely locked and there was thus no interruption | Tool is securely locked during the function test and the use | 120 cycles | After 120 cycles the tool was securely locked and there was no interruption. PASS | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Elan 4 Bench Testing Craniotome Handpiece Summary Table | Requirement | Acceptance Criteria | Sample Size | Results | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Tools can be attached automatically and released manually | Tool can be consistently coupled and uncoupled | 123 cycles | After 123 cycles the tool was automatically coupled and manually decoupled with no problems. PASS | | No performance or safety impairments were caused by cleaning, disinfecting or steam sterilization | Reprocessing procedure does not cause any functional or safety impairments | 123 cycles | No performance or safety impairments caused by cleaning, disinfecting or sterilization. Weight remained constant | | To evaluate the acceptance criteria, all analysis of all of the other acceptance criteria can be used. Since all other acceptance criteria were "satisfied" rated, this also applies to requirement (5). After and during 123 application and processing cycles, there was no functional and safety impairments. | All other testing requirements must be passed | 123 cycles | Since all other acceptance criteria were satisfied this requirement can be determined to have met acceptance criteria. PASS | | After 123rd processing and application cycles all relevant information (manufacturer, part number, serial number) the labels are still identifiable / readable. | Labels and other identifying information remains readable after set amount of reprocessing cycles | 123 cycles | After 123 cycles all relevant information are still identifiable/readable. PASS | | 123 times 'OK' motor cable could be easily coupled and uncoupled | Motor cable consistently couples and uncouples | 123 cycles | After 123 cycles motor cables are easily coupled/uncoupled. PASS | | 123 times 'no' at 123 cycles there was no interruption of operation due to release of cable | No safety or function impairments due to cable release | 123 cycles | After 123 cycles there was no interruption of operation due to cable release. PASS | | 123 times 'no' at 123 cycles there was no interruption of operation due to failure of electrical components | No safety or function impairments due to failure of electrical components | 123 cycles | After 123 cycles there was no interruption of operation due to failure of electrical components. PASS | | 123 times 'no' at 123 cycles there was no interruption of operation due to failure of mechanical components | No safety or function impairments due to failure of mechanical components | 123 cycles | After 123 cycles there was no interruption of operation due to failure of mechanical components. PASS | | 123 times 'no' at 123 cycles the tool was securely locked and there was thus no interruption | No safety or function impairments due to failure or tool lock mechanism | 123 cycles | After 123 cycles the tool was securely locked and there was no interruption. PASS | | Temperature measurement: Check temperature of hand-piece at 3 defined times during the course of the 123 cycle test | Temperature remains in acceptable range throughout testing | 123 cycles | 10th, 51st, and 101st cycle are all PASS | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ # Elan 4 Bench Testing Perforator Summary Table | Requirement | Acceptance Criteria | Sample Size | Results | |------------------------------------------------|------------------------------------------------------------------------------------------------|-------------|---------| | Processing test (See below for sub-tests) | | | | | Sterilization Test (Processing sub-test 1) | Reprocessing does not result in any functional or safety issues | 100 cycles | PASS | | Bracket System Test (Processing sub-test 2) | Motors held securely during processing | 100 cycles | PASS | | Function Test (Processing sub- test 3) | Tool securely locked and could be safely removed | 100 cycles | PASS | | Plug Testing (Processing sub-test 4) | Motor cable was safe, easy and error-free coupling and uncoupling | 100 cycles | PASS | | Lubrication Testing (Processing sub-test 5) | Lack of lubrication did not cause impairment of function or safety | 100 cycles | PASS | | Perforation Test | Perforator broke through material and turned off automatically after breaking through | 100 cycles | PASS | {12}------------------------------------------------ | Weight and Temperature Test | Perforator hand piece maintained a consistent weight and temperature range throughout testing | 100 cycles | PASS | |--------------------------------|--------------------------------------------------------------------------------------------------------|------------|------| |--------------------------------|--------------------------------------------------------------------------------------------------------|------------|------| # Elan 4 Bench Testing Reciprocating Saw Handpiece Summary Table | Requirement | Acceptance Criteria | Sample Size | Results | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------| | Cleaning and Disinfection Test | No functional or safety issues caused by cleaning and disinfection procedures | 100 cycles | PASS | | Sterilization Test | No functional or safety issues caused by sterilization procedure. | 100 cycles | PASS | | Bracket Test | Saw held securely during reprocessing, transport and storage | 100 cycles | PASS | | Lubrication Test | No impairment of safety or function due to lack of lubrication | 100 cycles | PASS | | Function Test | Tool is static and locked securely. Tool can be safely removed. Oscillation of tool functions. No functional or safety issues as a result of material changes | 100 cycles | PASS | | Motor Cable Test | Motor cable can be coupled and uncoupled safely, easily, and without error. | 100 cycles | PASS | | Performance Test | Sawing motion (oscillation) is consistent and cut is at least 6cm. | 100 cycles | PASS | | Temperature Measurement Test | Temperature remains in acceptable range throughout testing | 100 cycles (temperature measured every 20 cycles) | PASS | {13}------------------------------------------------ | Requirement | Acceptance Criteria | Sample Size | Results | |--------------------|-------------------------------------------------------------------------------------------|-------------|---------| | Cleaning Test | No function or safety issues as a result of the cleaning and disinfection procedure | 100 cycles | PASS | | Sterilization Test | No function or safety issues as a result of the sterilization procedure | 100 cycles | PASS | | Bracket Test | Saw remained secure during reprocessing, transport and | 100 cycles | PASS | | Lubrication Test | No safety or function issues due to lack of lubrication | 100 cycles | PASS | | Motor Cable Test | No impairment of the connection and disconnection process | 100 cycles | PASS | | Performance Test | Sawing motion and cut is constant and consistent | 100 cycles | PASS | | Temperature Test | Temperature remains in acceptable range throughout testing | 100 cycles | PASS | ## Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table ### SUBSTANTIAL EQUIVALENCE CONCLUSION Bench testing results along with a comparison between the technology and materials used in the ELAN 4 Electro Motor System and the predicate device, demonstrates that the ELAN 4 Electro Motor System meets or exceeds the performance of the predicate device. Bench testing for each handpiece was conducted with pass/fail criteria that would demonstrate equivalent or improved performance in comparison to the predicate as intended in the specified use conditions. The bench testing results and technological comparison demonstrate that the ELAN 4 Electro Motor System performs comparably to the predicate device currently marketed.

ELAN 4 Motor System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Submission Summary (Full Text)

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ELAN 4 Motor System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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