(263 days)
No
The summary describes mechanical cutting tools and does not mention any AI/ML capabilities or related performance metrics.
No
The device is described as cutting tools for bone, which are used to assist in surgical procedures rather than directly treating a disease or condition.
No
The device is described as a cutting, sawing, and drilling tool for bone, which is an interventional function, not a diagnostic one.
No
The device description explicitly states the ELAN 4 Tools are physical cutting devices made of stainless steel, some with diamond chips, designed for use with a motor system. This indicates a hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 device is described as "cutting devices designed for use with the ELAN 4 Electro Motor System" for "cutting, sawing and drilling of bone." This further reinforces its role as a surgical tool.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
The information provided clearly indicates that the Aesculap ELAN 4 Tools are surgical instruments used directly on the patient's bone during surgery, not for in vitro diagnostic testing.
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
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 with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).
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
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.
- Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogen testing. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion.
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.
- The ELAN 4 Tools are packaged and sterilized by gamma irradiation.
- Packaging is validated per ISO 11607. Testing per ASTM F1980 validated the 5 year shelf life. 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: Rotating performance test for rotating tools
-
Test Summary: Design suitable for speeds up to 80,000 rpm for 2 minutes
-
Results: Pass
-
Study Type: Measurement of temperature
-
Test Summary: With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting
-
Results: Pass
Key Metrics
Not Found
Predicate Device(s)
ELAN 4 Tools (K172709), Anspach Dissection Tools (K113476)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2019
Aesculap, Inc. Kathy A. Racosky Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
Re: K183203
Trade/Device Name: Aesculap 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: July 11, 2019 Received: November 19, 2018
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Matthew Krueger, M.S.E. 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)
K183203 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
July 17, 2019 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| 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: | HRE |
SUBSTANTIAL EQUIVALENCE
The ELAN 4 Tools are substantially equivalent to the primary predicate, ELAN 4 Tools (K172709) and predicate Anspach Dissection Tools (K113476).
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 with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).
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, ELAN 4 Tools (K172709) and the reference predicate Anspach Dissection Tools (K113476). 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 and indications for use. The subject device has the same sizes and manufacturing materials as the reference predicate. A comparison table summarizing these characteristics can be found below.
The ELAN 4 Tools offer similar components when compared to the primary predicate, ELAN 4 Tools (K172709). The proposed device has some differences from the primary predicate device. The subject device ranges in sizes from 0.5 mm to 8 mm versus 0.6 mm to 9 mm for the predicate device. The subject device is manufactured from stainless steel with some tools containing a layer of diamond chips whereas the predicate is made from stainless steel. Similar to the devices that are subject to this submission, the predicate. Anspach Dissection Tool (K113476) are manufactured from the same materials; stainless steel with some tools containing a layer of diamond chips and range in the same sizes as the subject device offers.
| K# | Aesculap Inc.
ELAN 4 Tools | Aesculap Inc.
ELAN 4 Tools | Anspach Dissection Tool |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Proposed device | K172709 - Primary | K113476 |
| 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. | 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. |
| Regulation number | 882.4310 | 882.4310 | 882.4310 |
| Product Code | HBE | HBE | HBE |
| Regulatory Panel | Neurology | Neurology | Neurology |
| Tools | | | |
| Burrs & drills | | | |
| --Size | 0.5 mm to 8 mm | 0.6 mm to 9 mm | 0.5 mm to 24.5 mm |
| --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 | fluted, ball, conical, oval,
barrel, acorn, pin, twist,
drills, cutters, and discs |
| Materials | Stainless steel & diamond | Stainless steel | Stainless steel, diamond,
carbide |
| Attachment mechanism | Yes | Yes | Yes |
| Sterile Single Use | Yes | Yes | Yes |
| Sterilization | GAMMA irradiation | GAMMA irradiation | unknown |
5
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.
Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogen testing. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion.
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.
The ELAN 4 Tools are packaged and sterilized by gamma irradiation.
Packaging is validated per ISO 11607. Testing per ASTM F1980 validated the 5 year shelf life. 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 | ||
| rotating tools | Design suitable for speeds up | |
| to 80,000 rpm for 2 minutes | Pass | |
| Measurement of temperature | With constant pressure and | |
| regular irrigation, evaluated | ||
| bone temperature increase | ||
| after milling, drilling or | ||
| cutting | Pass |
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Page 4 of 4
CONCLUSION:
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.