The ELAN 4 Tools are cutting devices designed solely for use with the ELAN 4 Electro Motor System. The ELAN 4 Electro Motor System 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 either a diamond coated or tungsten carbide head. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.

AI/ML Overview

This document describes the premarket notification for the Aesculap ELAN 4 Tools (K182527), which are intended for high speed cutting, sawing, and drilling of bone. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria for an AI/ML powered device.

Therefore, many of the requested details about acceptance criteria, study design for AI, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as this is a traditional medical device submission, not an AI/ML device submission.

Here's a breakdown of the information that can be extracted and where details are not applicable (N/A) or not provided (NP) given the nature of this submission:

1. A table of acceptance criteria and the reported device performance

For this traditional medical device, the "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device through design, materials, and performance testing (like biocompatibility and bench testing, rather than clinical performance metrics for an AI algorithm).

Acceptance Criteria Category	Specific Test/Comparison Point	Reported Device Performance (Summary)
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Pyrogen testing per ISO 10993-1	All tests passed, demonstrating biological safety and substantial equivalence to predicate devices.
Bench Testing - Rotational Performance	Determine suitability for speeds up to 100,000 rpm (for burrs and disc)	Passed ("Design not suitable, suitable for speeds up to 100,000 rpm" - Note: The wording here is a bit ambiguous, but implying it meets the capability.)
Bench Testing - Temperature Measurement	Evaluate bone temperature increase after milling, drilling, or cutting with constant pressure and regular irrigation	Passed ("With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting")
Technological Characteristics Comparison to Predicate (Anspach Dissection Tools K113476)	Indications for Use	Substantially equivalent ("The ELAN Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery." vs. "Dissection tools are intended for cutting and shaping bone including spine and cranium.")
	Regulation number, Product Code, Regulatory Panel	Identical (882.4310, HBE, Neurology)
	Burrs & drills - Size	Similar (0.6 mm to 25 mm for subject vs. 0.5 mm to 24.5 mm for predicate)
	Burrs & drills - Type	Identical (fluted, ball, conical, oval, barrel, acorn, pin, twist, drills, cutters, and discs)
	Materials	Similar (Stainless steel, diamond, tungsten carbide for subject vs. Stainless steel, diamond, carbide for predicate)
	Attachment mechanism	Yes for both
	Sterile Single Use	Yes for both
	Sterilization	GAMMA irradiation for subject, unknown for predicate (but implies predicate is sterile)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: N/A (This is a traditional mechanical device, not an AI/ML system that uses a 'test set' in the same way for performance evaluation on predictive tasks.) The "tests" here refer to physical product testing (e.g., biocompatibility on samples, bench testing on devices).
Data Provenance: N/A (Not relevant for this type of device submission.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A (Ground truth in the context of an AI/ML test set is not applicable here. The "truth" is established through physical/material properties and mechanical performance specifications.)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A (Not applicable for this type of device testing.)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, and thus no MRMC study or human-in-the-loop performance evaluation was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a surgical tool, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., ISO for biocompatibility), and direct physical measurements (e.g., temperature, rotational speed tolerances).

8. The sample size for the training set

N/A. This is not an AI/ML device; there is no 'training set' in this context.

9. How the ground truth for the training set was established

N/A. Not applicable.

Summary

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January 19, 2019

Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K182527

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: December 20, 2018 Received: December 20, 2018

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

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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/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

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Indications for Use

510(k) Number (if known) K182527

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)
X Prescription Use (Part 21 CER 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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B. 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap ELAN 4 Tools December 20, 2018

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (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 theiraccessories
REGULATION NUMBER:	882.4310
PRODUCT CODE:	HBE

SUBSTANTIAL EQUIVALENCE

The ELAN 4 Tools are substantially equivalent to the predicate, Anspach Dissection Tools (K113476) and the reference device, Aesculap ELAN 4 Electro Motor System (K152960).

DEVICE DESCRIPTION

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.

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TECHNOLOGICAL CHARACTERISTICS (compared to predicate)

The ELAN 4 Tools are substantially equivalent to the predicate, Anspach Dissection Tools (K113476) and the reference device 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 ranges in sizes 0.6 mm to 25 mm versus 0.5 mm to 24.5 mm for the predicate device (K113475). 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
K#	Proposed device	K113476 - Primary
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.
Regulation number	882.4310	882.4310
Product Code	HBE	HBE
Regulatory Panel	Neurology	Neurology
Burrs & drills
--Size	0.6 mm to 25 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
Materials	Stainless steel, diamond, tungsten carbide	Stainless steel, diamond, carbide
Attachment mechanism	Yes	Yes
Sterile Single Use	Yes	Yes
Sterilization	GAMMA irradiation	unknown

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.

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Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogen testing.

A biological risk assessment was conducted in order to evaluate the overall biological safety of the ELAN 4 Tools. The results of this testing demonstrated that the ELAN 4 Tools are substantially equivalent to the predicate devices.

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 forburrs and disc	Design not suitable, suitablefor speeds up to 100,000 rpm	Pass
Measurement of temperature	With constant pressure andregular irrigation, evaluatedbone temperature increaseafter milling, drilling orcutting	Pass

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.

Regulation Number and Section

§ 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).