(105 days)
The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Unibody Fiducial Marker System." This type of letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics and is considered as safe and effective.
However, a 510(k) clearance does not typically include the detailed acceptance criteria or the specific study results proving those criteria were met in the way a clinical trial report or a comprehensive technical document would. The FDA letter is a regulatory approval document, not a scientific publication of study findings.
Therefore,Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" but does not define specific performance metrics or acceptance criteria, nor does it report the device's performance against them.
- Sample size used for the test set and the data provenance: No information about a test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not mention any ground truth establishment for a test set or the involvement of experts for this purpose.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information is available regarding an adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a physical "Fiducial Marker System," not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance is not applicable and not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a physical medical device, not an algorithm, a standalone performance study in this context is not relevant and not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information about ground truth is provided.
- The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as there's no training set mentioned.
The document's primary purpose is to grant regulatory clearance by establishing substantial equivalence to a predicate device, not to detail specific performance studies or their methodologies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2004
Mr. David M. Lee Director of Regulatory Affairs Image-Guided Neurologics 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K033619
Trade/Device Name: Navigus Unibody Fiducial Marker System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 14, 2004 Received: January 15, 2004
Dear Mr. Lec:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected. 9 retty pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate (of use stated in the enclosure) (o regar) the enactment date of the Medical Device Amendments, or to conninered process that have been recordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Tion (110) that the device, subject to the general controls provisions of the Act. The r ou may, moreloro, mains of the Act include requirements for annual registration, listing of general oonlines provisions 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 If your device is clusion of too as controls. Existing major regulations affecting your device can may be subject to sach additional results , 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 1 lease of advised that 1191 bilseanter over device complies with other requirements of the Act that I DX has made a asid regulations administered by other Federal agencies. You must or any I cactar stutures and registeries, including, but not limited to: registration and listing (21 Comply with an the Act 81equirements, and manufacturing practice requirements as set CI K Furt 6075, adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. David M. Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms reter nation. The FDA finding of substantial equivalence of your device to a legally promanced 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), please If you dosire specific acreoliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033619
Device Name: Navigus Unibody Fiducial Marker System
Indications For Use: The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Muriami C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
KO33619 510(k) Number_
§ 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).