(236 days)
Intended Use: The Navigus 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. The device is provided sterile and for single use.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is primarily a 510(k) clearance letter from the FDA for the 'Navigus Passive Probe', indicating that the device has been found substantially equivalent to a legally marketed predicate device.
Specifically, the text is missing information regarding:
- A table of acceptance criteria and reported device performance: This information is typically found in a summary of safety and effectiveness, which is not part of this clearance letter.
- Sample size used for the test set and data provenance: No details about a test set or its origin are present.
- Number and qualifications of experts: No mention of experts or ground truth establishment.
- Adjudication method: Not discussed in the document.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No information about such a study or effect sizes is provided.
- Standalone performance: No details about the algorithm's performance without human intervention.
- Type of ground truth used: The document does not describe the ground truth for any study.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The document only states the device's intended use and that it received 510(k) clearance. To find the information you're looking for, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often includes more detailed safety and effectiveness data.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 4 - 2004
Mr. David M. Lee Director of Regulatory Affairs Image Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32951
Re: K040334
Trade/Device Name: Navigus Passive Probe Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 8, 2004 Received: September 9, 2004
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to 112) 2011 11:12 provisions of the Federal Food, Drug, de noos mat have been reat 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 I ou may, increrey missions 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 hay or dayser to data time to a segulations, 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 or car) i 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.
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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 his letter with anow you to begin mailing of substantial equivalence of your device to a legally premarket notification. The PDA maing of basification 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 darres 101 your as (301) 594-4659. Also, please note the regulation entitled, Comacs the Office of Compunise in the notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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
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): KO40334
Navigus Passive Probe Device Name:
Indications For Use:
Intended Use: The Navigus 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. The device is provided sterile and for single use.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Misian C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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| 510(k) Number | K040334 |
|---|---|
| --------------- | --------- |
§ 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).