(289 days)
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 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.
The provided document details the acceptance criteria and study results for the ELAN 4 Electro Motor System.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents several tables detailing acceptance criteria and results for different handpieces of the ELAN 4 Electro Motor System. Below is a consolidated representation of these, focusing on the general themes rather than repeating every specific test if the acceptance criteria and results are similar across different components.
| Requirement / Test Category | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Handpieces (GA) | ||
| Material change (Titanium alloy to Stainless steel) | No new risk to patient. (Verified by testing and biocompatibility testing per ISO 10993-1) | Pass. Does not raise new questions of safety and effectiveness. |
| Material change (PEEK (blue) to PEEK (black)) | No new risk to patient. (Verified by testing) | Pass. Does not raise new questions of safety and effectiveness. |
| Motor and handpiece has no coupling (one piece) | No new risk to patient. (Verified by testing) | Pass. Does not raise new questions of safety and effectiveness. |
| Tool adaptation at distal end of handpiece | No new risk to patient. (Verified by testing) | Pass. Does not raise new questions of safety and effectiveness. |
| Burr release only in off position mechanism | No new risk to patient. (Verified by testing) | Pass. Does not raise new questions of safety and effectiveness. |
| Bench Testing of ELAN 4 Attachments (General) | ||
| Contour milling performance (Drill hand pieces GA861 and GA864) | As representative of the standard tool portfolio "XS", contour milling is per application and processing cycle with the test pattern to be milled in bone replacement material (ash hardwood). Definition of the tools used. | 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 decoupled (with actuator). | 120 times "OK", i.e., at 120 cycles of use, the tool was automatically coupled and uncoupled manually. There were no problems with tool coupling. PASS. |
| Function/Safety after Cleaning, Disinfection, Sterilization | No impairment of function and safety by cleaning, disinfection and steam sterilization. | During the preparation and application of 120 cycles, there were no function and safety impairments caused by cleaning, disinfection and steam sterilization. PASS. (Weight remained constant before/after processing cycle). |
| Overall Functional and Safety Impairments during/after cycles | No impairment of function and safety during and after at least 100 applications and processing cycles. | 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. PASS. |
| Label Readability | Labels are still readable after min. 100 application and processing cycles. | After 120 cycles all relevant information are still identifiable/readable. PASS. |
| Motor Cable Coupling/Uncoupling Ease | Motor cable can be coupled and uncoupled. | 120 times "OK", i.e. at 120 cycles of use, the motor cables could be easily coupled and uncoupled. PASS. |
| No Operation Interruption from Cable Release | No interruption of operation by releasing the cable. | 120 times "no", i.e. at 120 cycles of use, there was no interruption of operation through the cable. PASS. |
| No Operation Interruption from Electrical Component Failure | No interruption of operation due to failure of electrical components. | 120 times "no", i.e. at 120 cycles of use, there was no operation interruption due to failure of electrical components. PASS. |
| No Operation Interruption from Mechanical Component Failure | No interruption of operation due to failure of mechanical components. | 120 times "no", i.e. at 120 cycles of use, there was no interruption due to failure of mechanical components. PASS. |
| Tool Securely Locked During Use | Tool is securely locked during the function test and the use. | 120 times "no", i.e. at 120 cycles of use the tool during application was securely locked and there was thus no interruption. PASS. |
| Elan 4 Bench Testing Craniotome Handpiece Summary Table | ||
| Tool coupling/uncoupling | Tool can be consistently coupled and uncoupled. | After 123 cycles the tool was automatically coupled and manually decoupled with no problems. PASS. |
| Reprocessing Procedure (Cleaning, Disinfecting, Steam Sterilization) | Reprocessing procedure does not cause any functional or safety impairments. | No performance or safety impairments caused by cleaning, disinfecting or sterilization. Weight remained constant. PASS. |
| Overall Functional and Safety Impairments | All other testing requirements must be passed. | Since all other acceptance criteria were satisfied this requirement can be determined to have met acceptance criteria. PASS. |
| Label Readability | Labels and other identifying information remains readable after set amount of reprocessing cycles. | After 123 cycles all relevant information are still identifiable/readable. PASS. |
| Motor Cable Consistency | Motor cable consistently couples and uncouples. | After 123 cycles motor cables are easily coupled/uncoupled. PASS. |
| No Cable Release Safety/Function Impairment | No safety or function impairments due to cable release. | After 123 cycles there was no interruption of operation due to cable release. PASS. |
| No Electrical Component Failure | No safety or function impairments due to failure of electrical components. | After 123 cycles there was no interruption of operation due to failure of electrical components. PASS. |
| No Mechanical Component Failure | No safety or function impairments due to failure of mechanical components. | After 123 cycles there was no interruption of operation due to failure of mechanical components. PASS. |
| Tool Lock Mechanism Integrity | No safety or function impairments due to failure or tool lock mechanism. | After 123 cycles the tool was securely locked and there was no interruption. PASS. |
| Temperature Measurement (Hand-piece) | Temperature remains in acceptable range throughout testing. | 10th, 51st, and 101st cycle are all PASS. |
| Elan 4 Bench Testing Perforator Summary Table | ||
| Sterilization Test | Reprocessing does not result in any functional or safety issues. | PASS. |
| Bracket System Test | Motors held securely during processing. | PASS. |
| Function Test | Tool securely locked and could be safely removed. | PASS. |
| Plug Testing | Motor cable was safe, easy and error-free coupling and uncoupling. | PASS. |
| Lubrication Testing | Lack of lubrication did not cause impairment of function or safety. | PASS. |
| Perforation Test | Perforator broke through material and turned off automatically after breaking through. | PASS. |
| Weight and Temperature Test | Perforator hand piece maintained a consistent weight and temperature range throughout testing. | PASS. |
| Elan 4 Bench Testing Reciprocating Saw Handpiece Summary Table | ||
| Cleaning and Disinfection Test | No functional or safety issues caused by cleaning and disinfection procedures. | PASS. |
| Sterilization Test | No functional or safety issues caused by sterilization procedure. | PASS. |
| Bracket Test (for saw) | Saw held securely during reprocessing, transport and storage. | PASS. |
| Lubrication Test (for saw) | No impairment of safety or function due to lack of lubrication. | PASS. |
| Function Test (for saw) | 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. | PASS. |
| Motor Cable Test (for saw) | Motor cable can be coupled and uncoupled safely, easily, and without error. | PASS. |
| Performance Test (Sawing motion) | Sawing motion (oscillation) is consistent and cut is at least 6cm. | PASS. |
| Temperature Measurement Test (for saw) | Temperature remains in acceptable range throughout testing. | PASS. |
| Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table | ||
| Cleaning Test | No function or safety issues as a result of the cleaning and disinfection procedure. | PASS. |
| Sterilization Test | No function or safety issues as a result of the sterilization procedure. | PASS. |
| Bracket Test (for saw) | Saw remained secure during reprocessing, transport and storage. | PASS. |
| Lubrication Test (for saw) | No safety or function issues due to lack of lubrication. | PASS. |
| Motor Cable Test (for saw) | No impairment of the connection and disconnection process. | PASS. |
| Performance Test (Sawing motion) | Sawing motion and cut is constant and consistent. | PASS. |
| Temperature Test (for saw) | Temperature remains in acceptable range throughout testing. | PASS. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size:
- For the "ELAN 4 Bench Testing Handpieces Summary Table" and "ELAN 4 Bench Testing Craniotome Handpiece Summary Table," the sample size for most tests was 120-123 cycles.
- For the "ELAN 4 Bench Testing Perforator Summary Table," "ELAN 4 Bench Testing Reciprocating Saw Handpiece Summary Table," and "Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table," the sample size for most tests was 100 cycles.
- Data Provenance: The studies described are bench tests, meaning they were conducted in a controlled laboratory environment rather than on human or animal subjects. The document does not specify the country of origin of the data, but the context implies it was conducted by Aesculap, Inc., whose address is in Center Valley, PA, USA. These are prospective tests designed to demonstrate device performance against predefined criteria.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided in the document. The studies are bench tests, and the "ground truth" implicitly refers to engineering specifications and performance criteria that the device is expected to meet. It's not a clinical study requiring human experts to establish diagnostic ground truth.
4. Adjudication Method for the Test Set:
- This information is not applicable as the studies are bench tests with clearly defined pass/fail criteria based on engineering specifications. There is no mention of human adjudication for these technical performance tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document describes bench testing comparing the ELAN 4 Electro Motor System to its predicate device based on technological characteristics and performance in a controlled environment. It does not involve human readers or AI assistance.
6. Standalone Performance Study (Algorithm only without human-in-the loop performance):
- Yes, the studies described are analogous to standalone performance studies for mechanical devices. The ELAN 4 Electro Motor System was tested in a standalone capacity (i.e., the device itself, without human intervention in the evaluation of the test results beyond operating the equipment and recording data) against predefined performance criteria. There is no "algorithm" in the sense of AI; it's the mechanical/electrical device's performance that is being evaluated.
7. Type of Ground Truth Used:
- The ground truth used is primarily engineering specifications and predefined performance criteria. For example, a burr should not release during use, labels should remain readable after a certain number of cycles, and temperature should remain within an acceptable range. These are objective, measurable parameters.
8. Sample Size for the Training Set:
- This concept is not applicable to the described studies. The document describes verification and validation bench testing for a physical medical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable as it is not a study involving a training set for an AI/machine learning model. The ground truth for the verification and validation (bench testing) was established through engineering specifications and safety requirements relevant to the device's function.
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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.
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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
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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)
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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 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Peter Stoll610-984-9076 (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
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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 | VerificationActivity | AcceptanceCriteria | Results ofVerification |
|---|---|---|---|---|
| handpieces (GA) | ||||
| material change fromtitinium alloy to stainlesssteel | No new risk topatient. | Verificationtesting andbiocompatibilitytesting per ISO10993-1 | Engineeringspecification | Pass. Does notraise newquestions ofsafety andeffectiveness. |
| material change fromPEEK (blue) to PEEK(black) | No new risk topatient. | Verificationtesting (also seeAppendix Abelow) | Engineeringspecification | Pass. Does notraise newquestions ofsafety andeffectiveness. |
| motor and handpiece hasno coupling (one piece) | no new risk topatient | Verificationtesting (also seeAppendix Abelow) | Engineeringspecification | Pass. Does notraise newquestions ofsafety andeffectiveness. |
| tool adaption at distal endof handpiece | no new risk topatient | Verificationtesting (also seeAppendix Abelow) | Engineeringspecification | Pass. Does notraise newquestions ofsafety andeffectiveness. |
| burr release only in offposition mechanism | no new risk topatient | Verificationtesting (also seeAppendix Abelow) | Engineeringspecification | Pass. Does notraise newquestions ofsafety andeffectiveness. |
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 |
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| speed | ||
|---|---|---|
| Voltage | 100-240 V | 100 - 240V |
| Frequency | 50-60Hz | 50 - 60Hz |
| IrrigationPump | Yes | Yes |
| Motor | ||
| High speedmotorMin/Max | 10,000/ 80,000 rpm | 5,000 rpm / 80,000 rpm |
| Low speedmotorMin/Max | 1,000/ 20,000 rpm | 3,000 rpm / 40,000 rpm |
| MotorrotationHigh 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 | ||
| Controlmechanism | Foot | Hand and foot |
| Ability toconnectvariousHandpieces | Yes | Yes |
| Motorconnections | 2 | 2 |
| Footswitchconnections | 1 | 1 |
| Control Unit | Touch screen | Touch screen |
| Appliedstandards | UL2601-1IEC60601-1IEC60601-1-2IEC62304 | UL2601-1IEC60601-1IEC60601-1-2 |
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 couldbe performed withoutaffecting the testpattern itself. | as representative of thestandard tool portfolio "XS"is per application andprocessing cycle with thetest pattern to be milled{Drill hand pieces GA861and GA864} in bonereplacement material {ashhardwood}. Definition ofthe tools used, | 120 cycles | The 120 applicationcycles, i.e. "a"contour millingcould be performedwithout affecting bythe test pattern itselfPass |
| CouplingToolfunctions | Tool ismanuallydecoupled {withactuator) | 120 times | 120 times "OK", ieat 120 cycles of use,the tool wasautomaticallycoupled anduncoupledmanually. Therewere no problemswith tool coupling.PASS |
| Determining theweight before theRDG / after theRDG / after theoiling / after theSterilization hasshown that theweight remainedconstant before andjust after the entireprocessing cycle. | No impairment of function andsafety by cleaning,Disinfection and steamsterilization | 120 cycles | During the preparationand application of 120cycles, there were nofunction and safetyimpairments caused bycleaning, disinfectionand steam sterilization.PASS |
| To evaluate theacceptance criteria, allanalysis of all of theother 20 acceptancecriteria can be used.Since all other 20acceptance criteriawere "satisfied" rated,this also applies torequirement (5). Afterand during 120application andprocessing cycles,there was nofunctional and safetyimpairments. | No impairment offunction and safetyduring and after at least100 applications andprocessing cycles | 120 cycles | Since all otheracceptance criteriawere satisfied thisrequirement can bedetermined to havemet acceptancecriteria. PASS |
| After 120thprocessing andapplication cycles allrelevant information(manufacturer, partnumber, serialnumber) the labelsare still identifiable /readable. | Labels are still readableafter min.100 applicationand processing cycles | 120 cycles | After 120 cycles allrelevant informationare stillidentifiable/readable.PASS |
| 120 times "OK", at120 cycles of use,the motor cablescould be easilycoupled anduncoupled. | Motor cable can becoupled and uncoupled | 120 cycles | After 120 cycles themotor cables could beeasilycoupled/uncoupled.PASS |
| 120 times "no", ie at120 cycles of use,there was nointerruption ofoperation throughthe cable | No interruption ofoperation by releasingthe cable | 120 cycles | After 120 cycles therewas no interruption ofoperation through thecable. PASS |
| 120 times "no", at120 cycles of use,there was nooperationinterruption due tofailure of electricalcomponents | interruption of operationdue to failure ofelectrical components | 120 cycles | After 120 cycles nooperation interruptiondue to failure ofelectricalcomponents. PASS |
| 120 times "no", ie at120 cycles of use,there was nointerruption due tofailure of mechanicalcomponents. | No interruption ofoperation due to failureof mechanicalcomponents | 120 cycles | After 120 cycles nooperation interruptiondue to failure ofmechanicalcomponents. PASS |
| 120 times "no", at120 cycles of use thetool duringapplication wassecurely locked andthere was thus nointerruption | Tool is securely lockedduring the function testand the use | 120 cycles | After 120 cycles thetool was securelylocked and there wasno interruption. PASS |
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Elan 4 Bench Testing Craniotome Handpiece Summary Table
| Requirement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|
| Tools can beattachedautomaticallyand releasedmanually | Tool can beconsistently coupledand uncoupled | 123 cycles | After 123 cycles the toolwas automaticallycoupled and manuallydecoupled with noproblems. PASS |
| No performance orsafety impairmentswere caused bycleaning,disinfecting or steamsterilization | Reprocessing proceduredoes not cause anyfunctional or safetyimpairments | 123 cycles | No performance orsafety impairmentscaused by cleaning,disinfecting orsterilization. Weightremained constant |
| To evaluate theacceptance criteria,all analysis of all ofthe other acceptancecriteria can be used.Since all otheracceptance criteriawere "satisfied"rated, this alsoapplies torequirement (5).After and during 123application andprocessing cycles,there was nofunctional and safetyimpairments. | All other testingrequirements must bepassed | 123 cycles | Since all otheracceptance criteria weresatisfied thisrequirement can bedetermined to have metacceptance criteria.PASS |
| After 123rdprocessing andapplication cycles allrelevant information(manufacturer, partnumber, serialnumber) the labelsare still identifiable /readable. | Labels and otheridentifyinginformation remainsreadable after setamount ofreprocessing cycles | 123 cycles | After 123 cycles allrelevant information arestillidentifiable/readable.PASS |
| 123 times'OK' motorcable couldbe easilycoupled anduncoupled | Motor cableconsistently couplesand uncouples | 123 cycles | After 123 cycles motorcables are easilycoupled/uncoupled.PASS |
| 123 times'no' at 123 cycles therewas nointerruptionof operationdue to releaseof cable | No safety or functionimpairments due tocable release | 123 cycles | After 123 cycles therewas no interruption ofoperation due to cablerelease. PASS |
| 123 times'no' at 123 cycles therewas nointerruptionof operationdue to failureof electricalcomponents | No safety or functionimpairments due tofailure of electricalcomponents | 123 cycles | After 123 cycles therewas no interruption ofoperation due to failureof electricalcomponents. PASS |
| 123 times'no' at 123 cycles therewas nointerruptionof operationdue to failureofmechanicalcomponents | No safety or functionimpairments due tofailure of mechanicalcomponents | 123 cycles | After 123 cycles therewas no interruption ofoperation due to failureof mechanicalcomponents. PASS |
| 123 times'no' at 123 cycles thetool wassecurelylocked andthere wasthus nointerruption | No safety or functionimpairments due tofailure or tool lockmechanism | 123 cycles | After 123 cycles the toolwas securely locked andthere was nointerruption. PASS |
| Temperaturemeasurement:Checktemperatureof hand-pieceat 3 definedtimes duringthe course ofthe 123 cycletest | Temperature remainsin acceptable rangethroughout testing | 123 cycles | 10th, 51st, and 101stcycle are all PASS |
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Elan 4 Bench Testing Perforator Summary Table
| Requirement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|
| Processing test (See belowfor sub-tests) | |||
| Sterilization Test(Processing sub-test 1) | Reprocessing does notresult in any functional orsafety issues | 100 cycles | PASS |
| Bracket System Test(Processing sub-test 2) | Motors held securelyduring processing | 100 cycles | PASS |
| Function Test (Processing sub-test 3) | Tool securely lockedand could be safelyremoved | 100 cycles | PASS |
| Plug Testing(Processing sub-test 4) | Motor cable was safe,easy and error-freecoupling anduncoupling | 100 cycles | PASS |
| Lubrication Testing(Processing sub-test 5) | Lack of lubrication didnot cause impairmentof function or safety | 100 cycles | PASS |
| Perforation Test | Perforator broke throughmaterial and turned offautomatically afterbreaking through | 100 cycles | PASS |
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| Weight andTemperature Test | Perforator hand piecemaintained a consistentweight and temperaturerange throughout testing | 100 cycles | PASS |
|---|---|---|---|
| -------------------------------- | -------------------------------------------------------------------------------------------------------- | ------------ | ------ |
Elan 4 Bench Testing Reciprocating Saw Handpiece Summary Table
| Requirement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|
| Cleaning andDisinfection Test | No functional or safety issuescaused by cleaning anddisinfection procedures | 100 cycles | PASS |
| SterilizationTest | No functional or safety issuescaused by sterilizationprocedure. | 100 cycles | PASS |
| Bracket Test | Saw held securely duringreprocessing, transport andstorage | 100 cycles | PASS |
| Lubrication Test | No impairment of safety orfunction due to lack oflubrication | 100 cycles | PASS |
| Function Test | Tool is static and lockedsecurely. Tool can be safelyremoved. Oscillation of toolfunctions. No functional orsafety issues as a result ofmaterial changes | 100 cycles | PASS |
| Motor CableTest | Motor cable can be coupledand uncoupled safely, easily,and without error. | 100 cycles | PASS |
| PerformanceTest | Sawing motion (oscillation)is consistent and cut is atleast 6cm. | 100 cycles | PASS |
| TemperatureMeasurementTest | Temperature remains inacceptable range throughouttesting | 100 cycles(temperaturemeasured every 20cycles) | PASS |
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| Requirement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|
| Cleaning Test | No function or safety issues asa result of the cleaning anddisinfection procedure | 100 cycles | PASS |
| Sterilization Test | No function or safety issues as aresult of the sterilizationprocedure | 100 cycles | PASS |
| Bracket Test | Saw remained secure duringreprocessing, transport and | 100 cycles | PASS |
| Lubrication Test | No safety or function issuesdue to lack of lubrication | 100 cycles | PASS |
| Motor Cable Test | No impairment of theconnection and disconnectionprocess | 100 cycles | PASS |
| Performance Test | Sawing motion and cut isconstant and consistent | 100 cycles | PASS |
| Temperature Test | Temperature remains inacceptable range throughouttesting | 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.
§ 882.4360 Electric cranial drill motor.
(a)
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.(b)
Classification. Class II (performance standards).