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.

Device Description

The HiLan Motor System for Neurosurgery consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various cranial handpieces (craniotome and perforator). The system components connect to each other via a proprietary coupling system.

AI/ML Overview

The provided text describes a 510(k) submission for the Aesculap HiLan Motor System for Neurosurgery. This document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study with specific acceptance criteria and performance data for a new, AI-powered device.

Therefore, many of the requested sections about acceptance criteria, study design, and AI-specific details cannot be fulfilled from the provided text. The device described, a pneumatic motor system for surgery, predates common AI applications in medical devices.

Here's an attempt to address the points based on the available information, with clear indications where the information is not present:

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

Acceptance Criteria (Not Explicitly Stated for this Device as a "New" Performance Study)	Reported Device Performance (Based on Substantial Equivalence Claim)
Technological Characteristics: Identical to predicate device (K973736).	The HiLan Motor System for Neurosurgery is identical in all technological characteristics to the HiLan Pneumatic Motor System which was cleared in K973736.
Intended Use: For use in surgical procedures to provide power to operate removable cutting tools or drill bits on a patient's skull, indicated for neurosurgery.	Intended use matches the described function.
Safety: Manufactured in accordance with relevant standards (ISO, German Din).	Manufactured in accordance with ISO and German Din Standards; Aesculap AG has ISO 9001 certification.
Functionality: Shares similar features and function with predicate and other marketed devices.	Shares similar features and function with corresponding devices distributed by Aesculap, Hall/Zimmer, and Midas Rex.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This document does not describe a performance study with a test set of data. The submission relies on demonstrating substantial equivalence to a prior device clearance (K973736).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No ground truth establishment is described as this is not a performance study.

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

Not applicable/Not provided. No adjudication method is described.

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

Not applicable. This device is a pneumatic motor system, not an AI or diagnostic imaging device. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a physical surgical tool, not an algorithm.

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

Not applicable/Not provided. No ground truth is established as this is not a performance study comparing a new device feature or diagnostic capability. The "ground truth" for substantial equivalence is the previously cleared device itself.

8. The sample size for the training set

Not applicable/Not provided. No training set is involved for this type of device submission.

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

Not applicable/Not provided. No training set or ground truth for it is relevant to this device submission.

Summary of Device Acceptance:

The Aesculap HiLan Motor System for Neurosurgery was accepted for market clearance based on a 510(k) Substantial Equivalence pathway. The primary "study" (or justification) provided was the demonstration that the device is identical in all technological characteristics to a previously cleared predicate device, the HiLan Pneumatic Motor System (cleared under K973736). Additionally, it was stated to be manufactured in accordance with ISO and German Din Standards, and the manufacturer holds ISO 9001 certification, indicating adherence to quality management systems. The intended use also matched. Therefore, the FDA determined it was substantially equivalent to legally marketed predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the Aesculap logo. The logo consists of a square with a white circle inside, containing a symbol resembling a staff with a snake wrapped around it. To the right of the square is the word "AESCULAP" in bold, sans-serif font. The logo is simple and professional, likely representing a medical or healthcare-related organization.

K 980686

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990 Aesculap HilLan Motor System for Neurosurgery February 20, 1998

Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (650)876-7000 x348 FAX:

Aesculap HiLan Motor System for Product: Neurosurgery Pneumatic Cranial Drill Motor Common Name:

Device Description

Intended Use

Technological Characteristics

The HiLan Motor System for Neurosurgery is identical in all technological characteristics to the HiLan Pneumatic Motor System which was cleared in K973736.

Performance Standards

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Hilan Motor System for Neurosurgery is manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.

Substantial Equivalence

Aesculap's HiLan Motor System for Neurosurgery shares similar features and function with corresponding devices distributed by Aesculap , Hall/Zimmer and Midas Rex.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. Below the profiles are three wavy lines. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1998

Ms. Mary Ellen Holden Regulatory Associate Aesculap, Inc. 1000 Gateway Blvd. South San Francisco, California 94080

Re: K980686 Trade Name: Aesculap Hilan Motor System Regulatory Class: II Product Code: HBB Dated: February 20, 1998 Received: February 23, 1998

Dear Ms. Holden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary Ellen Holden

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known): K 98068b

Device Name:

Aesculap HilLan Motor System for Neurosurgery

Indication for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).