(147 days)
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Not Found
No
The summary describes a mechanical device for stereotactic delivery and makes no mention of AI or ML.
No
The device is described as an "introducer" for delivering neurosurgical instruments or devices, not as a device used to provide therapy itself. It facilitates therapeutic procedures but is not therapeutic in nature.
No
The device is intended for the stereotactic delivery of neurosurgical instruments during neurological procedures within the MRI environment, not for diagnosing conditions.
No
The description explicitly states the device is intended to provide "stereotactic delivery of neurosurgical instruments or devices," which implies a physical component for guiding and delivering instruments. It also mentions being used "in conjunction with MR imaging and guidance using the Navigus Trajectory Guide," further suggesting hardware involvement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stereotactic delivery of neurosurgical instruments or devices during planning and operation of neurological procedures within the MRI environment". This describes a device used in vivo (within the living body) for surgical guidance and instrument placement.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Anatomical Site: The anatomical site is "neurological," which refers to the nervous system within the body.
The device is a surgical guidance and delivery tool used directly on the patient during a procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Remote Introducer is intended to provide stereotactic delivery of newrosurgical instruments or devices during planning and operation of neurological nrocedures within the MRI environment and in conjunction with MR imaging and guidance using the Navigus Trajectory Guide. These procedures include catheter placement and electrode implant.
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
MR imaging
Anatomical Site
Neurological
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Mr. Michael J. Renner Vice President Image-Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K990907
Trade Name: Remote Introducer, Model P-1000 Regulatory Class: II Product Code: HAW Dated: June 7, 1999 Received: June 23, 1999
Dear Mr. Renner:
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 (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.
1
Page 2 – Mr. Michael J. Renner
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,
4 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
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Page / of
510(k) NUMBER (IF KNOWN) : 1990 70 7 DEVICE NAME: INDICATIONS FOR USE:
Intended Use: The Remote Introducer is intended to provide stereotactic delivery of newrosurgical instruments or devices during planning and operation of neurological nrocedures within the MRI environment and in conjunction with MR imaging and guidance using the Navigus Trajectory Guide. These procedures include catheter placement and electrode implant.
(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE. IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Dailes
(Division Sign-Off)
Division of General Restorative Devices K990907
510(k) Number
f