(404 days)
No
The device description and performance studies focus on mechanical and sterilization properties, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML.
No
The device is described as cutting devices used for high-speed cutting, sawing, and drilling of bone in various surgical fields, indicating an active surgical role rather than a therapeutic one.
No
Explanation: The device is described as cutting tools intended for high-speed cutting, sawing, and drilling of bone, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states the ELAN 4 Tools are "cutting devices" manufactured from "stainless steel" and are "components of the ELAN 4 Electro Motor System." This indicates a physical, hardware-based medical device, not software only. The performance studies also focus on physical properties like biocompatibility, sterilization, and bench testing of mechanical function.
Based on the provided information, the ELAN 4 Tools are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the ELAN 4 Tools are for "high speed cutting, sawing, and drilling of bone" in surgical procedures. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description reinforces that these are cutting devices used with a motor system for bone manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. The information provided focuses on the mechanical function and safety of the tools for surgical use.
Therefore, the ELAN 4 Tools are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
Aesculap ELAN 4 Tools are 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 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Biocompatibility Testing
- Study type: Biocompatibility testing (Cytotoxicity and Hemolysis testing) in accordance to ISO 10991-1 and Use of International Standard ISO 10993-1.
- Key Results: The biocompatibility test results yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.
Sterilization Validation
- Study type: Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006 and ISO 11137-2:2006.
- Key Results: Product sterilization is validated.
Packaging Validation
- Study type: Packaging validation per ISO 11607.
- Key Results: Accelerated aging data (5 years) for ELAN 4 Tools has been generated to support this submission. Bacterial Endotoxin testing per Endotoxin ISO 10993-5 met the acceptance criterion.
Bench Testing
- Study type: Bench testing to demonstrate performance and substantial equivalence.
- Rotating performance test for burrs and disc: Design suitable for speeds up to 100,000 rpm. Result: Pass.
- Functional testing of the tool adaptation with small blade: Distal tool adaptation and burr release mechanism, locks during use. Result: Pass.
- Measurement of oscillation frequency and fatigue test (small blade): Downforce oscillation output frequencies 0 to 20,000 rpm at the distal tool adaptation. Result: Pass.
- Measurement of oscillation frequency and fatigue test (large blade): Distal tool adaptation and burr release mechanism, locks during use. Downforce oscillation output frequencies 0 to 20,000 rpm at the distal tool adaptation. Result: Pass.
- Measurement of temperature: With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting. Result: 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.
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.
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
§ 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 shows 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.
October 17, 2018
Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K172709
Trade/Device Name: ELAN 4 Tools 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: September 7, 2017 Received: September 8, 2017
Dear Ms. 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
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 (OS) 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,
Matthew C. Krueger -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) K172709
Device Name Aesculap ELAN 4 Tools
Indications for Use (Describe)
Aesculap ELAN 4 Tools are 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) |
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Page 1 of 4
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap ELAN 4 Tools October 15, 2018
| 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@aesculapimplants.com |
| TRADE NAME: | ELAN 4 Tools |
| 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 |
SUBSTANTIAL EQUIVALENCE
The ELAN 4 Tools are substantially equivalent to the primary predicate, Anspach Dissection Tools (K113476) and the reference predicate, Aesculap ELAN 4 Electro Motor System (K152960).
DEVICE DESCRIPTION
The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.
INDICATIONS FOR USE
The ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
4
Page 2 of 4
TECHNOLOGICAL CHARACTERISTICS (compared to predicate)
The ELAN 4 Tools are substantially equivalent to the predicate, Anspach Dissection Tools (K113476) and the reference predicate ELAN 4 Electro Motor System (K152960). The subject device is shown to be substantially equivalent and has the same performance characteristics to its primary predicate device through comparison in design, principles of operation, intended use, and materials. The subject device has the exact same indications as the reference predicate. A comparison table summarizing these characteristics can be found below.
The ELAN 4 Tools offers similar components when compared to the primary predicate. Anspach Dissection Tools (K113475). The only difference is the subject device is also offered in a blade type design. Bench testing determined that the blade design does not raise new questions of safety and effectiveness. Similar to the devices that are subject to this submission, the reference predicate, ELAN 4 Electro Motor System (K152960) also has the same indications for use.
| | Aesculap Inc.
ELAN 4 Tools | Anspach Dissection Tool | Aesculap, Inc.
ELAN 4 Electro Motor
System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K172709 | K113476 - Primary | K152960 |
| Indications | The ELAN Tools are
intended for high speed
cutting, sawing, and
drilling of bone in the
fields of Spine, ENT,
Neuro, and Maxillofacial
Surgery. | Dissection tools are
intended for cutting and
shaping bone including
spine and cranium. | 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. |
| Regulation number | 882.4310 | 882.4310 | 882.4310 |
| Product Code | HBE | HBE | HBE |
| Regulatory Panel | Neurology | Neurology | Neurology |
| Tools | | | |
| Burrs & drills | | | |
| --Size | 0.6 mm to 9 mm | 0.5 mm to 24.5 mm | N/A |
| --Type | fluted, ball, conical, oval,
barrel, acorn, pin, twist,
drills, cutters, and discs | fluted, ball, conical, oval,
barrel, acorn, pin, twist,
drills, cutters, and discs | N/A |
| Blades | Sagittal & reciprocating | N/A | N/A |
| Materials | Stainless Steel | Stainless Steel, diamond | N/A |
| Attachment mechanism | Yes | Yes | N/A |
| Sterile Single Use | Yes | Yes | N/A |
| Sterilization | GAMMA irradiation | unknown | N/A |
PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility testing in accordance to ISO 10991-1 and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -1 Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff has been performed to demonstrate that the ELAN 4 Tools are substantially equivalent to other predicate devices.
5
Page 3 of 4
Biocompatibility testing within this submission includes Cytotoxicity and Hemolysis testing. The biocompatibility test results yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.
Sterilization Validation
Product sterilization is validated in accordance with the ANSI/AAMI/ ISO 11137-1:2006 -Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006 - Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.
Packaging is validated per ISO 11607. Accelerated aging data (5 years) for ELAN 4 Tools has been generated to support this submission. Bacterial Endotoxin testing per Endotoxin ISO 10993-5 met the acceptance criterion.
Bench Testing
The following bench testing was performed to demonstrate that the ELAN 4 Tools perform as intended and are substantially equivalent to the predicate devices.
| Test | Test Summary | Results |
|---|---|---|
| Rotating performance test for | ||
| burrs and disc | Design not suitable, suitable | |
| for speeds up to 100,000 rpm | Pass | |
| Functional testing of the tool | ||
| adaptation with small blade | Distal tool adaptation and | |
| burr release mechanism, | ||
| locks during use | Pass | |
| Measurement of oscillation | ||
| frequency and fatigue test | ||
| (small blade) | Downforce oscillation output | |
| frequencies 0 to 20,000 rpm | ||
| at the distal tool adaptation. | Pass | |
| Measurement of oscillation | ||
| frequency and fatigue test | ||
| (large blade) | Distal tool adaptation and | |
| burr release mechanism, | ||
| locks during use. Downforce | ||
| oscillation output frequencies | ||
| 0 to 20,000 rpm at the distal | ||
| tool adaptation. | Pass | |
| Measurement of temperature | With constant pressure and | |
| regular irrigation, evaluated | ||
| bone temperature increase | ||
| after milling, drilling or | ||
| cutting | Pass |
6
CONCLUSION:
Page 4 of 4
The biocompatibility and bench testing results along with a comparison between the technology, materials and intended use for the ELAN 4 Tools and the predicate devices demonstrate that the ELAN 4 Tools are as safe, as effective, and perform as well as the predicate devices. The biocompatibility and bench testing results and technological comparison demonstrates that the ELAN 4 Tools are substantially equivalent to the predicate devices.