(27 days)
Not Found
Not Found
No
The summary describes a passive probe used for patient registration and navigation in conjunction with a guidance system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical component and its intended use within a larger system.
No
The device is described as a "Reusable Passive Probe" intended for patient registration and navigation, used "in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System". This suggests it is a tool for guiding medical procedures rather than directly treating a disease or condition itself.
No
The provided text describes the device's use for patient registration and navigation, which are functions related to guiding treatment rather than diagnosing a condition. There is no mention of identifying, detecting, or assessing a disease or medical condition.
No
The device description explicitly states "Navigus Reusable Passive Probe," indicating a physical hardware component. The intended use also describes it being used "in conjunction with the Navigus family of trajectory guides," which are also likely physical devices.
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 "patient registration and navigation" in conjunction with other surgical guidance systems. This is a function related to surgical procedures and patient positioning, not the analysis of biological samples outside the body.
- Device Description: The description "Navigus Reusable Passive Probe" doesn't suggest any interaction with biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document lacks any mention of:
- Analyzing biological samples (blood, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Any of the typical components or processes associated with IVD devices (reagents, assays, etc.)
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that scope.
N/A
Intended Use / Indications for Use
The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.
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
Not Found
Indicated Patient Age Range
Not Found
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
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 208!50
Mr. David M. Lee Vice President of Quality and Regulatory Affairs Image-Guided Neurologics, Inc. 2290 West Eau Gallie Boulevard Melbourne, Florida 32935
Re: K050772
Trade/Device Name: Navigus Reusable Passive Probe Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 24, 2005 Received: March 25, 2005
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 taller work or 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must cormply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. David M. Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to ough finding of substantial equivalence of your device to a legally premarket notification: "The 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), please If you desire specific acrise ion your as (240) 276-0115 . Also, please note the regulation entitled, Colliation of Companyers of Company of College of (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ratha
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ravi.sed
Indications for Use
510(k) Number (if known): K050772
Device Name: Navigus Reusable Passive Probe
Indications For Use:
Intended Use: The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office: of Device Evaluation (ODE)
tive
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