(66 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML, and the device description is a standard navigation system.
No
The device provides image guidance during neurosurgical operations, which is an assistive tool for the surgeon, but it does not directly treat a disease or condition itself.
No
The text indicates the device provides image guidance and feedback during neurosurgical operations, which describes an assistive or guidance function rather than diagnosis. It does not state that it identifies a disease, condition, or provides a diagnosis.
No
The device description explicitly states "Nicolet Biomedical Electromagnetic Navigation System," which strongly implies a hardware component (electromagnetic navigation system) in addition to any potential software. The summary does not provide information to suggest it is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intra-operative image guidance during neurosurgical operations." This describes a device used during a surgical procedure on a patient, not a test performed outside the body on biological samples.
- Device Description: The description "Nicolet Biomedical Electromagnetic Navigation System" further supports the idea of a system used for navigation within the body during surgery.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on biological samples
Therefore, based on the provided text, the NEN is a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set. The device is to be used by or on order of a physician.
Product codes
90 LLZ
Device Description
Nicolet Biomedical Electromagnetic Navigation System
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
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Intended User / Care Setting
physician / intra-operative
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. David W. Wagner Director, Quality Assurance and Regulatory Affairs Nicolet Vascular, Inc. 6355 Joyce Drive GOLDEN CO 80403
Re: K013419
Trade/Device Name: Nicolet Biomedical Electromagnetic Navigation System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 5, 2001 Received: October 15, 2001
Dear Mr. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device weferenced 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 for association 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 I ou may , ater , worse , which , we , 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 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 comply 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
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 predication. - The PDF interestion 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 do Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Active of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compilance at (201) Pation" (21 CFR Part 807.97). Other general information on of forchase to premained from the Act may be obtained from the Division of Small Manufacturers, your rooponshill.co 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,
Nancy C. Crozier
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4013419
Application for 510(k)
Device Name: Nicolet Biomedical Electromagnetic Navigation System
Indications for Use:
The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set.
actors performed and passic device. The ultimate responsibility for how and where the surgical operation is conducted is the responsibility of the surgeon.
The device is to be used by or on order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Severson
Over-the-Counter Use
Prescription Use (per 21 CFR 801.109)