ELAN 4 Motor System

• K Number: K152960
• Device Name: ELAN 4 Motor System
• Manufacturer: AESCULAP, INC.
• Date Cleared: 2016-07-22 ( 289 days)
• Product Code: HBC HBE
• Regulation Number: 882.4360

Intended 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 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.

Predicate Devices

K053526

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical motor system for bone cutting and drilling. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are based on bench testing of mechanical function and safety.

Therapeutic

No.
The device is used for cutting, sawing, and drilling bone during surgical procedures, which are considered operative functions, not therapeutic.

Diagnostic

No
The device is described as an "Electro Motor System" intended for "high speed cutting, sawing, and drilling of bone." This indicates it is a surgical tool used for mechanical action, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it 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." This clearly indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "high speed cutting, sawing, and drilling of bone" during surgical procedures. This is a direct surgical intervention on the patient's body.
• Device Description: The description details a motor system with handpieces and attachments for physical manipulation of bone. This aligns with surgical tools, not diagnostic tests performed on samples outside the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HBE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

• Study Type: Bench Testing
• Sample Size: 120 cycles
• Key Results:
  • Contour milling could be performed without affecting the test pattern itself: Pass
  • Tool is manually decoupled (with actuator): Pass (120 times "OK", ie at 120 cycles of use, the tool was automatically coupled and uncoupled manually. There were no problems with tool coupling.)
  • 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: Pass
  • No impairment of function and safety during and after at least 100 applications and processing cycles: Pass
  • Labels are still readable after min.100 application and processing cycles: Pass
  • Motor cable can be coupled and uncoupled: Pass (After 120 cycles the motor cables could be easily coupled/uncoupled.)
  • No interruption of operation by releasing the cable: Pass
  • No interruption of operation due to failure of electrical components: Pass
  • No interruption of operation due to failure of mechanical components: Pass
  • Tool is securely locked during the function test and the use: Pass

Elan 4 Bench Testing Craniotome Handpiece Summary Table

• Study Type: Bench Testing
• Sample Size: 123 cycles
• Key Results:
  • Tools can be attached automatically and released manually: Pass
  • Reprocessing procedure does not cause any functional or safety impairments: Pass
  • All other testing requirements must be passed: Pass
  • Labels and other identifying information remains readable after set amount of reprocessing cycles: Pass
  • Motor cable consistently couples and uncouples: Pass
  • No safety or function impairments due to cable release: Pass
  • No safety or function impairments due to failure of electrical components: Pass
  • No safety or function impairments due to failure of mechanical components: Pass
  • No safety or function impairments due to failure or tool lock mechanism: Pass
  • Temperature remains in acceptable range throughout testing: Pass

Elan 4 Bench Testing Perforator Summary Table

• Study Type: Bench Testing
• Sample Size: 100 cycles
• Key Results:
  • Sterilization Test: PASS
  • Bracket System Test: PASS
  • Function Test: PASS
  • Plug Testing: PASS
  • Lubrication Testing: PASS
  • Perforation Test: PASS
  • Weight and Temperature Test: PASS

Elan 4 Bench Testing Reciprocating Saw Handpiece Summary Table

• Study Type: Bench Testing
• Sample Size: 100 cycles
• Key Results:
  • Cleaning and Disinfection Test: PASS
  • Sterilization Test: PASS
  • Bracket Test: PASS
  • Lubrication Test: PASS
  • Function Test: PASS
  • Motor Cable Test: PASS
  • Performance Test: PASS
  • Temperature Measurement Test: PASS

Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table

• Study Type: Bench Testing
• Sample Size: 100 cycles
• Key Results:
  • Cleaning Test: PASS
  • Sterilization Test: PASS
  • Bracket Test: PASS
  • Lubrication Test: PASS
  • Motor Cable Test: PASS
  • Performance Test: PASS
  • Temperature Test: PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K053526

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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 [phone] or [phone] 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 [phone] or [phone] 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 [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

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.