(86 days)
Not Found
No
The summary describes a stereotactic system for mechanical guidance based on a preoperative plan and ultrasonic registration. There is no mention of AI, ML, or any learning algorithms used for image analysis, planning, or guidance.
No.
The device is a guidance system for neurosurgical instruments, primarily focused on spatial positioning and orientation. It does not exert a therapeutic effect on the patient itself.
No
The device description indicates it is a stereotactic system for guiding neurosurgical instruments, primarily for spatial positioning and orientation, rather than for diagnosing medical conditions. Its function is procedural assistance, not diagnostic analysis or detection.
No
The device description explicitly mentions an "electromechanical, multijointed arm," which is a hardware component, indicating it is not a software-only device.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a stereotactic system used for spatial positioning and orientation of surgical instruments during neurosurgery. It guides the surgeon's hand based on a preoperative plan.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is purely mechanical guidance within the surgical field.
Therefore, this device falls under the category of a surgical guidance system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A computer-controlled image-guided electromechanical multijointed arm, intended to be used in a neurosurgical operating room for the stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments, under a surgeon-developed, carefully prepared stereotactic treatment plan.
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
A stereotactic system with an electromechanical, multijointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical operating room / neurosurgeous
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
§ 882.4560 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
JUN 25 1999
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SUMMARY OF SAFETY AND EFFECTIVENESS
- Frameless NeuroMate DEVICE NAME (Trade, common, and classification): 1.0 Stereotactic System.
- PREDICATE DEVICE(s): K963256. 2.0
- DESCRIPTION: A stereotactic system with an electromechanical, multijointed arm 3.0 for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.
- 4.0 USE: A computer-controlled image-guided electromechanical INTENDED multijointed arm, intended to be used in a neurosurgical operating room for the stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments, under a surgeon-developed, carefully prepared stereotactic treatment plan.
- INDICATION FOR USE: Stereotactic spatial positioning and orientation of an રું રા instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
- BASIS OF REQUEST: The following factors are the basis of our request for a 6.0 finding of substantial equivalency:
- No substantive change in materials, basic components, or method of 6.1 manufacture between this device and the predicate device; the system and its components have been used in the medical device industry for similar or identical products and for similar or identical uses with no record of any patient problems, adverse reactions;
- 6.2 No change in basic construction;
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- The device and its components have been tested by independent labs for EMC 6.3. and safety, EU standards compliance, and will be subjected to inspection and testing at IQA, and during/after manufacture and upon installation in the field; and
- The function and use of this product will be no different than that of predicate 6.4. devices and other similar devices currently in the marketplace.
- 7.0 No substantive differences exist between the SUBSTANTIVE DIFFERENCES: product defined in this 510(k) submission and the predicate device, except the registration system, which is similar to that currently used in other medical devices, and the incorporation of a commercially available imaging software for stereotactic planning, which has been developed, verified and validated to applicable standards, and guidance documents, cited herein.
Signed: ___ Dated: 3/29/99
RD Hibbert Director of Clinical and Regulatory Affairs Integrated Surgical Systems, Inc. 1850 Research Drive Davis, CA 95616 Fax: 530-792-2690 Phone: 530-792-2621
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1999
Mr. R. D. Hibbert Director Clinical and Regulatory Affairs Integrated Surgical Systems 1850 Research Park Drive Davis. California 95616
Re: K991081
Trade Name: Frameless NeuroMate Stereotactic System Regulatory Class: II Product Code: HAW Dated: March 29, 1999 Received: March 31, 1999
Dear Mr. Hibbert:
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 – Mr. R. D. Hibbert
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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Frameless NeuroMate
Indications For Use:
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of General Restorative Devices ( 510(k) Number
Prescription Use_xx (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)