(245 days)
K811452, Preamendment device
No
The device description details a mechanical positioning system with a motorized lead-screw for one axis, driven by simple micrometer screws for the others. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis. The performance studies focus on accuracy and repeatability of the mechanical movement.
No
The device is a positioning system for probes and electrodes, not a therapeutic device itself. It facilitates precise placement for procedures like recording, stimulation, or lesioning, which may be therapeutic, but the device's function is purely mechanical manipulation.
No
The device is a micropositioner used for precise placement of probes for procedures like electrophysiological recording, stimulation, or lesioning, not for diagnosing a condition.
No
The device description clearly states it is a "three-axis positioning device" with "micrometer screws" and a "motorized lead-screw arrangement," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Guideline System 3000 MP-1 Micropositioner is a mechanical device used for the precise physical placement of probes or electrodes within the nervous system during surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes its function in surgical procedures for placing probes for recording, stimulation, or lesioning within the patient's body.
The device is a surgical instrument used for precise manipulation during neurosurgical procedures, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Guideline System 3000 MP-1 Micropositioner is intended for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.
Product codes
HAW
Device Description
The MP-1 Micropositioner is a three-axis positioning device for precise manipulation of probes or electrodes in stereotactic neurosurgical procedures. The "x" and "y" axes are driven by simple micrometer screws, while the "z" or depth axis is driven by a motorized lead-screw arrangement. The positioner allows for the accurate placement of probes within the three dimensional stereotactic space once it has been mounted on a legally marketed stereotactic frame.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain, spinal cord, or other part of the nervous system
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
The Guideline System 3000 MP-1 Micropositioner has been demonstrated to perform as intended with accuracy and repeatability. In accordance with our development plan, the Guideline System MP-1 Micropositioner has been extensively tested in both bench test and animal test conditions. Prototype instruments meet or exceed all appropriate Feature and Engineering Specifications and tolerances.
Key Metrics
Not Found
Predicate Device(s)
K811452, Preamendment device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary and saftey and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION
Company Name:
Company Address:
Foster City, CA 94404
Axon Instruments, Inc.
1101 Chess Drive
Company Phone: Company Fax:
(650) 571-9400 (650) 571-9500
Contact Person:
Andrew Blatz, Ph.D. Regulatory Affairs Manager Product-Line Manager Neurosurgical Devices Axon Instruments, Inc.
Date Summary Prepared:
January 7, 1999
DEVICE IDENTIFICATION
Trade/Proprietary Name:
Guideline System 3000 MP-1 Micropositioner
Classification Name:
Stereotaxic Instruments and Accessories
1
IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Radionics | Brown-Roberts-Wells | ||
| Stereotaxic System | K811452 | 6/1/81 | |
| Radionics | Semi-Micro-Electrode Kit | Preamendment | |
| device | Not applicable |
DEVICE DESCRIPTION
The MP-1 Micropositioner is a three-axis positioning device for precise manipulation of probes or electrodes in stereotactic neurosurgical procedures. The "x" and "y" axes are driven by simple micrometer screws, while the "z" or depth axis is driven by a motorized lead-screw arrangement. The positioner allows for the accurate placement of probes within the three dimensional stereotactic space once it has been mounted on a legally marketed stereotactic frame.
SUBSTANTIAL EQUIVALENCE
The Guideline System 3000 MP-1 Micropositioner is substantially equivalent to the predicate devices. The intended use, labeling, physical characteristics, and safety features of the Guideline System MP-1 Micropositioner and the predicate devices are very similar, differing only in details that have no bearing on safety and effectiveness. The technologies involved in both the predicate devices and the Guideline System 3000 MP-1 Micropositioner are all time-tested, standard approaches and are listed in the comparison charts provided in this 510(k) submission.
INTENDED USE
The Guideline System 3000 MP-1 Micropositioner is intended for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
TECHNOLOGICAL CHARACTERSTICS
A comparison of the technological characteristics of the MP-1 Micropositioner to the predicate and legally marketed devices is provided within this submission.
2
PERFORMANCE DATA
The Guideline System 3000 MP-1 Micropositioner has been demonstrated to perform as intended with accuracy and repeatability. In accordance with our development plan, the Guideline System MP-1 Micropositioner has been extensively tested in both bench test and animal test conditions. Prototype instruments meet or exceed all appropriate Feature and Engineering Specifications and tolerances.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1999
James C. Makous, Ph.D. Product Line Manager, Neurosurgical Devices Axon Instruments, Inc. 1101 Chess Drive Foster City, California 94404
Re: K990683 Trade Name: Axon MP-1 Micropositioner Regulatory Class: II Product Code: HAW Dated: August 4, 1999 Received: August 5, 1999
Dear Dr. Makous:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
4
Page 2 - James C. Makous, Ph.D.
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,
Collie M. Wilson, Ph.D., M.P.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
622 510(k) Number (if known):
Device Name: MP-1 Micropositioner
Indications for Use:
The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sedo
(Division Sign-Off)
Division of General Restorative Devices K99068)
510(k) Number
Prescription Use
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)