(191 days)
Not Found
No
The summary describes a pneumatic motor system with mechanical components and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a surgical tool used to cut or drill, not to treat a disease or condition for therapeutic purposes.
No
The device is described as a pneumatic motor system that powers surgical tools for cutting and drilling on a patient's skull during neurosurgery. Its function is to operate on the patient, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components: a hand held motor, air hose, foot control, pneumatic motor hose, and various cranial handpieces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide power to operate removable cutting tools or drill bits on a patient's skull" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The components described (motor, hoses, foot control, handpieces) are all mechanical tools used for physical manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, tissue, urine, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose or provide information about a disease or condition.
This device is a surgical tool used in vivo (within the body) during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HBB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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)
Not Found
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.
Not Found
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
§ 882.4370 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).
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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
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.
Intended Use
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 patients skull. It is indicated for use in neurosurgery.
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.
1
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:
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.
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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)