(245 days)
No
The summary describes a standard electrical motor system for surgical procedures and does not mention any AI or ML capabilities.
Yes
The device is used for high-speed cutting, sawing, and drilling of bone in various surgical fields, which are therapeutic interventions.
No
This device is an electro motor system intended for high-speed cutting, sawing, and drilling of bone in various surgical fields. Its function is to perform surgical procedures, not to diagnose a condition.
No
The device description explicitly states that the ELAN 4 Electro Motor System includes a control unit, hand-pieces with integrated motors, and attachments (burrs, saw blades, drills). While software is mentioned as part of the system, it is clearly integrated into and controls hardware components.
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" in surgical fields. This describes a surgical tool used directly on a patient's body.
- Device Description: The description details an electrical motor system with hand-pieces, attachments (burrs, saw blades, drills), and a foot control. This aligns with a surgical power tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is used for surgical procedures on the human body.
N/A
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 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc.
The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.
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
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:
In house design verification testing was performed to ensure that mechanical and functional requirements including design specifications were met. All tests completed met their preestablished acceptance criteria.
- Test: Ensuring the function between two service intervals for the ELAN 4 Electric Drill. Test Method Summary: Demonstrate functionality, performance characteristics and the safety of the product based on the intended use within service interval of one year. Results: Pass: All requirements met.
- Test: Verification of the reactions times of the ELAN 4 Wireless Foot Control. Test Method Summary: Demonstrate the reaction time in the time between changing the logic level of the function and change in the button status byte. Results: Pass: All requirements met.
Biocompatibility:
A biocompatibility evaluation was conducted according to International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, as appropriate for limited exposure (
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2021
Aesculap Inc. Kathy Racosky Project Manager I 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K203739
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: July 28, 2021 Received: July 28, 2021
Dear Kathy Racosky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203739
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) | |
|---|---|
|X 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 Software V3.00, Wireless Foot Control, Drill and Attachments August 24, 2021
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
610-984-9291 (phone)
610-791-6882 (fax)
kathy.racosky@aesculap.com |
| TRADE NAME: | ELAN 4 Electro Motor System |
| COMMON NAME: | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Powered simple cranial drills, burrs, trephines and their accessories |
| REGULATION NUMBER: | 882.4310 |
| PRODUCT CODE: | HBE |
Predicate device Aesculap ELAN 4 Electro Motor System, K152960. Reference device Aesculap Microspeed Uni Motor System, 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.
Device description
The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc.
The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.
4
Technological characteristic (compared to Predicate(s))
The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are substantially equivalent to the predicate. ELAN 4 Electro Motor System (K152960) and the reference predicate MicroSpeed Uni Motor System (K053526). The subject device is shown to be substantially equivalent and has the same performance characteristics to the primary predicate device through comparison in design, principles of operation and indications for use. The subject device offers similar components, operating speeds, and power sources as the predicate device. The proposed device has some differences in technological features in comparison to the predicate device. The proposed device has a wireless foot control versus the plug in foot control for the predicate device. The subject device is manufactured from Titanium, PEEK and Stainless Steel whereas the predicate device is made from PEEK and Stainless Steel. Similar to the devices that are subject to this submission, the reference predicate, is manufactured from Titanium. The subject device has a permanently attached motor cable when compared to the plug in motor cable of the predicate device. The device characteristics comparing the ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments to the predicate device are summarized in the substantial equivalence comparison table.
| System | ELAN 4 Electro Motor System | Predicate
ELAN 4 Electro Motor System | Reference Device
Microspeed Uni Motor System |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K203739 | 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. | 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. | 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: | | | |
| Software version | 3.00 | 1.03 | N/A |
| Foot Control: | | | |
| Type | Wireless | Plugs into control unit | Plugs into control unit |
| Activates motor of hand-piece | Yes | Yes | Yes |
| Controls | Speed, rotation and irrigation pump | Speed, rotation and irrigation pump | Speed, rotation and irrigation pump |
| Hand-piece: | | | |
| Type | Drill | Various | Various |
| Integrated motor | Yes | Yes | Yes |
| Motor cable | Permanent | Separate cable | Separate cable |
| Controls speed and rotation | Yes | No | No |
| Attachments | Yes | No | Yes |
| Motor: | | | |
| Low speed motor Min/Max | 1,000/ 20,000 rpm | 1,000/ 20,000 rpm | 3,000 rpm / 40,000 rpm |
5
| System | ELAN 4 Electro Motor
System | Predicate
ELAN 4 Electro Motor System | Reference Device
Microspeed Uni Motor
System |
|------------|---------------------------------------|------------------------------------------|----------------------------------------------------|
| K# | K203739 | K152960 | K053526 |
| Low speed | Left and right hand
rotation | Left and right hand rotation | Left and right hand rotation |
| Materials: | Titanium, PEEK and
Stainless Steel | PEEK and Stainless Steel | Titanium |
Performance data
The following performance data were provided in support of the substantial equivalence determination.
Bench testing
In house design verification testing was performed to ensure that mechanical and functional requirements including design specifications were met. All tests completed met their preestablished acceptance criteria.
| Test | Test Method Summary | Results |
|---|---|---|
| Ensuring the function | ||
| between two service | ||
| intervals for the ELAN 4 | ||
| Electric Drill | Demonstrate functionality, | |
| performance characteristics | ||
| and the safety of the product | ||
| based on the intended use | ||
| within service interval of one | ||
| year. | Pass: All requirements met | |
| Verification of the reactions | ||
| times of the ELAN 4 | ||
| Wireless Foot Control | Demonstrate the reaction time | |
| in the time between changing the | ||
| logic level of the function and change | ||
| in the button status byte | Pass: All requirements met |
Biocompatibility
A biocompatibility evaluation was conducted according to International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, as appropriate for limited exposure (≤ 24 hours) externally communicating device with contact in the area of tissue/bone/dentin devices.
The materials of the Wireless Foot Control. Drill and Attachments are the same types of materials used in the predicate and reference device. There have been no material changes since the clearance of the ELAN 4 Electro Motor System (K152960) and Microspeed Uni Motor System (K053526).
6
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the ELAN 4 Electro Motor System. The control unit, wireless foot control and drill were tested as part of the ELAN 4 Electro Motor System. The system complies with the IEC 60601-1 and UL 2601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor Injury.
Animal and Clinical Testing
No animal or clinical testing was necessary for determination of substantial equivalence.
Conclusion
Based on the indications for use, design, materials, function, comparison to the predicate device, and performance testing performed, it can be concluded that the ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are substantially equivalent to the predicate, ELAN 4 Electro Motor System (K152960).