(152 days)
Not Found
No
The summary describes a mechanical biopsy cannula and its compatibility with an image-guided surgery system, with no mention of AI or ML capabilities.
No.
The device is a biopsy cannula used to collect tissue, not to treat a disease or condition.
No
The device is a cannula used for biopsy, which is a procedure to collect tissue samples. While these samples are then used for diagnosis, the cannula itself is a surgical tool, not a diagnostic device that interprets medical data or provides a diagnosis.
No
The device description explicitly states it is a physical cannula made of stainless steel with components like an inner and outer cannula, a stop, and an aspiration tube. It is a hardware device used in conjunction with a navigation system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stereotaxic biopsy of cranial tissue." This describes a procedure to obtain a tissue sample from the brain.
- Device Description: The device is a "navigable brain biopsy cannula" used to collect tissue.
- Function: The device's function is to physically collect a tissue sample.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
This device is used in vivo (inside the body) to obtain the specimen. The analysis of the collected tissue sample would likely be performed using IVD devices, but the cannula itself is a surgical instrument for tissue collection, not an IVD.
N/A
Intended Use / Indications for Use
The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.
Product codes
HAW
Device Description
The MDT Navigable Brain Biopsy Cannula contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotaxic biopsy of cranial tissue. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System. Like the predicate devices, both devices are pre-sterilized, single-use, stainless steel devices and use a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
The MDT Navigable Brain Biopsy Cannula components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial tissue, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: trained healthcare professional
Care Setting: healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was conducted to demonstrate that the MDT Navigable Brain Biopsy Cannula performed as intended and is comparable to the predicate device. Tissue extraction testing was conducted to verify the ability of the device to sample tissue. Navigation testing was conducted to verify the compatibility of the devices with the Medtronic StealthStation® IGS systems. These studies verify that the device is comparable with the legally marketed predicate device identified above.
Key Metrics
Not Found
Predicate Device(s)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
IZI Medical Products % Mr. Qiang Cao Manager of Ouality Assurance and Regulatory Affairs 5 Easter Court, Suite J Owings Mills, Maryland 21117
Re: K143241 Trade/Device Name: MDT Navigable Brain Biopsy Cannula Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 10, 2015 Received: March 12, 2015
Dear Mr. Qiang Cao,
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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143241
Device Name MDT Navigable Brain Biopsy Cannula
Indications for Use (Describe)
The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Submitter
IZI Medical Products LLC 5 Easter Court, Suite J Owings Mills, MD 21117
Phone: (410) 594-9403 Fax: (410) 594-0540
Contact Person: Qiang Cao Date Prepared: April 7, 2015
II. Device
Trade Name: MDT Navigable Brain Biopsy Cannula
Common or Usual Name: Stereotaxic Biopsy Needle
Classification Name: Neurological Stereotaxic Instrument (21 CFR 882.4560)
Product Code: HAW (Neurological Stereotaxic Instrument)
III. Predicate Devices
Medtronic Biopsy Needle (K971247)
Device Description IV.
The MDT Navigable Brain Biopsy Cannula contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotaxic biopsy of cranial tissue. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System. Like the predicate devices, both devices are pre-sterilized, single-use, stainless steel devices and use a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
The MDT Navigable Brain Biopsy Cannula components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
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V. Intended Use of the Device
The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.
Patient Population
The device is intended for use in patients undergoing stereotaxic brain biopsy procedures.
Environment of Use
The device is intended for use by a trained healthcare professional in a healthcare facility.
VI. Summary of Technological Characteristics
The MDT Navigable Brain Biopsy Cannula contains a navigable biopsy cannula constructed with an inner and outer stainless steel cannula with a side-cutting window, a plastic hub and a set of retro-reflective elements. The reflection elements allow the cannula to be registered with the Medtronic's StealthStation® Image Guided Surgery System and to be visible during a biopsy procedure. The Product also contains a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
The MDT Navigable Brain Biopsy Cannula is comparible to the Medtronic Biopsy Needle Kit (K971247) regarding its intended use, functional and dimensional characteristics, and overall performance. Minor dimensional differences between the devices have no impact on safety or effectiveness.
| Technical
Characteristics | Subject Device
(K143241) | Medtronic Biopsy Needle
(K971247) | Comparison |
|---------------------------------------|-----------------------------|--------------------------------------|------------|
| Needle/Cannula
Material | Stainless steel (AISI 304) | Stainless steel (AISI 304) | Identical |
| Biopsy Needle/Cannula
Construction | Inner and outer cannula | Inner and outer cannula | Identical |
| Biopsy Cutting Action | Side cutting window | Side cutting window | Identical |
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| Registration and
| Tracking Method | Retro-reflective material | Retro-reflective material | Identical |
|---|---|---|---|
| Compatible IGS | Medtronic | ||
| StealthStation® | Medtronic StealthStation® | Identical | |
| Needle Dimension | |||
| (diameter) | 2.1 mm | 2.1 mm | Identical |
VII. Summary of Performance Testing
Bench testing was conducted to demonstrate that the MDT Navigable Brain Biopsy Cannula performed as intended and is comparable to the predicate device. Tissue extraction testing was conducted to verify the ability of the device to sample tissue. Navigation testing was conducted to verify the compatibility of the devices with the Medtronic StealthStation® IGS systems. These studies verify that the device is comparable with the legally marketed predicate device identified above.
VIII. Conclusion
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the MDT Navigable Brain Biopsy Cannula device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the MDT Navigable Brain Biopsy Cannula device performs comparably to the predicate device that is currently marketed for the same intended use.