(134 days)
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No
The summary describes a mechanical stereotactic arc system for surgical guidance, with no mention of AI, ML, or related concepts in the device description, intended use, or other sections.
No
The device is used for guiding and holding instruments for neurosurgery, not for directly treating a disease or condition.
No
The device is described as an arc system for adjusting instrument trajectories and holding instruments for neurosurgical applications. Its function is to guide and hold instruments, not to diagnose a condition.
No
The device description explicitly states it is a "stereotactic arc," which is a physical hardware component used in neurosurgery.
Based on the provided information, the BrainLAB Stereotactic Arc system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications." This describes a device used directly on or in the patient during a surgical procedure, not for analyzing samples outside the body.
- Anatomical Site: The anatomical site is "neurosurgical applications," which involves procedures on the brain or nervous system.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, laboratory testing, or any of the typical characteristics of an IVD.
Therefore, the BrainLAB Stereotactic Arc system is a surgical device used for guidance and instrument holding during neurosurgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications in x,y,z directions and in azimuthal and declination angles requiring coordinate-accurate imaging-guided target localization and instrument guidance.
Product codes
HAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2000
Mr. Fotios Nisiropoulos Project Manager BrainLAB AG 100 Marine Parkway, Suite 305 Redwood City, California 94065
K992916 Re: Trade Name: BrainLab Stereotactic Arc Regulatory Class: II Product Code: HAW Dated: November 18, 1999 Received: November 26, 1999
Dear Mr. Nisiropoulos:
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.
1
Page 2 -- Mr. Fotios Nisiropoulos
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,
Styt Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
×992916
Device Name:
BrainLAB Stereotactic Arc
Indications For Use:
The BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications in x,y,z directions and in azimuthal and declination angles requiring coordinate-accurate imaging-guided target localization and instrument guidance.
(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 | K992916 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |
| (Optional Format I-2-96) |