(410 days)
No
The description focuses on the mechanical and pneumatic aspects of the device, with no mention of AI or ML capabilities. The control is described as manual via a foot pedal.
No
The device is described as a surgical tool used for "high speed cutting, sawing, and drilling of bone," which is an intervention rather than a therapeutic treatment.
No
The device description clearly states its purpose is for "high speed cutting, sawing, and drilling of bone," which are therapeutic surgical actions, not diagnostic ones.
No
The device description clearly outlines a system composed of physical components such as a pneumatic motor, wall adaptors, foot pedals, and handpieces with integrated motors and attachments (burrs, saw blades, drills). This is a hardware-based medical device, not software-only.
Based on the provided information, the ELAN 4 Air Motor System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details a pneumatic motor system with handpieces, burrs, saw blades, and drills. These are all components of a surgical instrument.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The ELAN 4 Air Motor System does not perform this function.
Therefore, the ELAN 4 Air Motor System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Product codes
HBB
Device Description
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery. The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.
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)
Design Verification:
-
Test: Ensuring the function between two service intervals - Motor hose with manual control
- Test Method Summary: Demonstrate functionality, performance features and the safety of the product based on the intended use within a service / Maintenance interval of (one year).
- Results: Pass: All requirements met
-
Test: Ensuring the function between two service intervals for perforator motor
- Test Method Summary: Demonstrate functionality, performance features and the safety of the product based on the intended use within a service / Maintenance interval of (one year).
- Results: Pass: All requirements met
-
Test: Ensuring the function between two service intervals - ELAN 4 AIR Micros-Sagittal Saw
- Test Method Summary: Demonstrate functionality, performance features safety of the product
- Results: Pass: All requirements met
-
Test: Ensuring the function between two service intervals - ELAN 4 AIR Micro-Reciprocating Saw
- Test Method Summary: Demonstrate functionality, performance features safety of the product
- Results: Pass: All requirements met
-
Test: Ensuring the function between two service intervals - ELAN 4 air high speed Handpiece
- Test Method Summary: Demonstrate functionality, performance features and the safety of the product based on the intended use within a service / Maintenance interval of (one year).
- Results: Pass: All requirements met
-
Test: Verification of ELAN 4 Air Foot Control
- Test Method Summary: Simulation of an application of one year for the detection of functionality, Performance and safety of the product
- Results: Pass: All requirements met
Biocompatibility:
- Biocompatibility testing within this submission includes cytotoxicity and hemolysis testing. The biocompatibility test results for cytotoxicity and hemolysis yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ELAN 4 Electro Motor System (K152960)
Reference Device(s)
Aesculap® HiLan Motor System for Neurosurgery (K980686)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
November 9, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aesculap, Inc. Jessica Stigliano Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K172907
Trade/Device Name: ELAN 4 Air Motor System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: Class II Product Code: HBB Dated: April 2, 2018 Received: April 4, 2018
Dear Jessica Stigliano:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
John Marler -S
For
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172907
Device Name ELAN 4 Air Motor System
Indications for Use (Describe)
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Reproduction Use (Part 21 CFR 601 Subpart E) |
|---|
| ☐ Same as Type Certification (21 CFR 601 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY (as required by 21 CFR 807.92)
ELAN 4 Air Motor System
November 8, 2018
| COMPANY: | Aesculap®®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Jessica Stigliano
610-984-9063 (phone)
610-791-6882 (fax)
jessica.stigliano@Aesculapimplants.com |
| TRADE NAME: | ELAN 4 Air Motor System |
| COMMON NAME: | Motor, drill, Pneumatic |
| REGULATION NUMBER: | 882.4370 - Pneumatic cranial drill motor |
| PRODUCT CODE: | HBB |
| REVIEW PANEL: | Neurology |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the ELAN 4 Air Motor System is substantially equivalent to the primary predicate, ELAN 4 Electro Motor System (K152960), and reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686).
DEVICE DESCRIPTION
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT. Neuro, and Maxillofacial Surgery. The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.
INDICATIONS FOR USE
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
B.
4
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))
The ELAN 4 Air Motor System is substantially equivalent to the primary predicate, ELAN 4 Electro Motor System (K152960), and reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686). The subject device is shown to be substantially equivalent and has the same performance characteristics to its primary predicate device and reference predicate device through comparison in design, principles of operation, intended use, and materials. A comparison table summarizing these characteristics can be found below.
The ELAN 4 Air Motor System offers similar components, attachments, and operating speeds when compared to the primary predicate. The main difference between the ELAN 4 Air Motor System and the ELAN 4 Electro Motor System is the source of power for the motor. The ELAN 4 Electro Motor System is operated by an electric motor, while the ELAN 4 Air Motor System is operated by a pneumatic motor. There is no software involved in the ELAN 4 Air Motor System. Similar to the devices that are subject to this submission, the reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686) also uses a pneumatic power source.
| System | ELAN 4 Air Motor
System (subject of this
submission) | Primary predicate:
ELAN 4 Electro Motor
System (K152960) | Reference predicate:
Aesculap® HiLan Motor
System for Neurosurgery
(K980686) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ELAN 4 Air Motor
System is intended for
high speed cutting,
sawing, and drilling of
bone in the fields of
Spine, ENT, Neuro, and
Maxillofacial Surgery. | 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 HiLan Motor
System for Neurosurgery is a
pneumatic motor system
intended for use in surgical
procedures to provide power to
operate removable cutting
tools or drill bits on a patient's
skull. It is indicated for use in
neurosurgery. |
| Motor | | | |
| Power | Pneumatic | Electric | Pneumatic |
| High speed motor
Min/Max | 10,000/ 80,000 rpm | 10,000/ 80,000 rpm | Max: 90,000 rpm |
| Low speed motor
Min/Max | 1,000/ 20,000 rpm | 1,000/ 20,000 rpm | Max: 75,000 rpm |
| Motor rotation
High speed | Right hand/Clockwise | Left and right hand
rotation | Left and right hand rotation |
| Low speed | Left and right hand
rotation | Left and right hand
rotation | Left and right hand rotation |
| Materials | PEEK and Stainless
Steel | PEEK and Stainless Steel | Stainless Steel |
| Features | | | |
| Control mechanism
for speed | Foot Pedal | Foot Pedal | Foot Pedal |
5
| Ability to connect
| various Handpieces | Yes | Yes | Yes |
|---|---|---|---|
| Footswitch | |||
| connections | 1 | 1 | 1 |
PERFORMANCE DATA
Design Verification
| Test | Test Method Summary | Results |
|---|---|---|
| Ensuring the function | ||
| between two service | ||
| intervals - Motor hose | ||
| with manual | ||
| control | Demonstrate functionality, performance features and the | |
| safety of the product based on the intended use within a | ||
| service / Maintenance interval of (one year). | Pass: All requirements met | |
| Ensuring the function | ||
| between two service | ||
| intervals for perforator | ||
| motor | Demonstrate functionality, performance features and the | |
| safety of the product based on the intended use within a | ||
| service / Maintenance interval of (one year). | Pass: All requirements met | |
| Ensuring the function | ||
| between two service | ||
| intervals - ELAN 4 AIR | ||
| Micros-Sagittal Saw | Demonstrate functionality, performance features safety of | |
| the product | Pass: All requirements met | |
| Ensuring the function | ||
| between two service | ||
| intervals - ELAN 4 AIR | ||
| Micro-Reciprocating | ||
| Saw | Demonstrate functionality, performance features safety of | |
| the product | Pass: All requirements met | |
| Ensuring the function | ||
| between two service | ||
| intervals - ELAN 4 air | ||
| high speed Handpiece | Demonstrate functionality, performance features and the | |
| safety of the product based on the intended use within a | ||
| service / Maintenance interval of (one year). | Pass: All requirements met | |
| Verification of ELAN 4 | ||
| Air Foot Control | Simulation of an application of one year for the detection of | |
| functionality, Performance and safety of the product | Pass: All requirements met |
Biocompatibility
The materials in the ELAN 4 Air Motor System are exactly the same materials used in the ELAN 4 Electro Motor System. There have been no materials changes since the clearance of the ELAN 4 Electro Motor System (K152960). The ELAN 4 Air Motor System materials and biocompatibility conform to the following standards;
ISO 10993-1: Evaluation and testing within a risk management process ISO 7153-1: Surgical instruments -- Metallic materials -- Part 1: Stainless steel
6
Biocompatibility testing within this submission includes cytotoxicity and hemolysis testing. The biocompatibility test results for cytotoxicity and hemolysis yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.
CONCLUSION
The design verification and biocompatibility information along with a comparison between the technology, materials and intended use for the ELAN 4 Air Motor System and the predicate devices demonstrate that the ELAN 4 Air Motor System is as safe, as effective, and performs as well as the predicate devices. The design verification, biocompatibility information and technological comparison demonstrates that the ELAN 4 Air Motor System is substantially equivalent to the predicate devices.