(259 days)
Not Found
No
The summary describes a mechanical biopsy needle used with a navigation system, with no mention of AI or ML in its function or description.
No
The device is a biopsy needle used to collect tissue samples for diagnostic purposes, not to treat a disease or condition.
No.
This device, the BL Navigated Biopsy Needle, is used for stereotactic biopsy, which involves collecting tissue samples. While these samples may subsequently be used for diagnosis, the device itself is an instrument for obtaining the sample, not for performing the diagnostic analysis or reaching a diagnosis directly.
No
The device description explicitly states it is a "pre-sterilized, single-use, stainless steel device" with physical components like a cannula, stop, and aspiration tube, indicating it is a hardware medical 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 "stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system." This describes a surgical procedure to obtain a tissue sample from the body.
- Device Description: The device is a "pre-sterilized, single-use, side-cutting needle" used for "stereotactic biopsy of cranial tissue." It's a tool for physically extracting tissue.
- Lack of IVD Characteristics: 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's function is to obtain the tissue sample, not to analyze it.
The device is a surgical instrument used in vivo (within the body) to collect a sample for potential subsequent in vitro diagnostic testing, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of crainlab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
BL Navigated Biopsy Needle contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotactic biopsy of cranial tissue. The device is compatible with specified BrainLab navigation systems (see intended use section below). Like the predicate device, the BL Navigated Biopsy Needle is a pre-sterilized, single-use, stainless steel device and uses a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
BL Navigated Biopsy Needle's components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
The BL Navigated Biopsy Needle contains a navigable biopsy cannula constructed with an inner and outer stainless steel needle with a side-cutting window, a plastic hub and a set of retro-reflective discs. The reflective discs allow the device to be registered with BrainLab navigation systems and to be visible during a biopsy procedure. The Set also contains 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is intended for use by a trained healthcare professional in a 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate that the BL Navigated Biopsy Needle performs as intended and is substantially equivalent 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 and accuracy of the device with the specified navigation systems. Real-time shelf life testing was conducted to verify that there was no change in visual attributes, dimensional characteristics, or tensile strength after 5 years real time storage. These studies verify that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified above.
The biocompatibility evaluation for the BL Navigated Biopsy Needle was conducted in accordance with ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity and ANSI/AAMI ST72:2011 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. The battery of testing included the following tests:
- Cytotoxicity
- Pyrogen Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VectorVision Frameless Biopsy System (K012564), Medtronic Biopsy Needle (K971247)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
IZI Medical Products Qiang Cao Manager of Ouality Assurance and Regulatory Affairs 5 Easter Court, Suite J Owings Mills, MD 21117
Re: K140705 Trade/Device Name: Navigable Brain Biopsy Cannula Set Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 4, 2014 Received: November 6, 2014
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
1
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 同公
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) K140705
Device Name
IZI Navigable Brain Biopsy Cannula Set
Indications for Use (Describe)
The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of crainlab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) Owner
IZI Medical Products LLC
5 Easter Court, Suite J
Owings Mills, MD 21131
Phone: (410) 594-9403
Fax: (410) 594-0540
Date Summary Prepared: July 25, 2014
Device Name
Trade Name: BL Navigated Biopsy Needle
Common or Usual Name: Stereotactic Biopsy Needle
Classification Name: Neurological Stereotactic Instrument (21 CFR 882.4560)
Product Code: HAW (Neurological Stereotactic Instrument)
Predicate Device
VectorVision Frameless Biopsy System (K012564)
Medtronic Biopsy Needle (K971247)
Device Description
BL Navigated Biopsy Needle contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotactic biopsy of cranial tissue. The device is compatible with specified BrainLab navigation systems (see intended use section below). Like the predicate device, the BL Navigated Biopsy Needle is a pre-sterilized, single-use, stainless steel device and uses a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
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BL Navigated Biopsy Needle's components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
Indications for Use
The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.
Patient Population
The device is intended for use in patients undergoing stereotactic cranial tissue biopsy procedures.
Environment of Use
The device is intended for use by a trained healthcare professional in a healthcare facility.
Summary of Technological Characteristics
The BL Navigated Biopsy Needle contains a navigable biopsy cannula constructed with an inner and outer stainless steel needle with a side-cutting window, a plastic hub and a set of retro-reflective discs. The reflective discs allow the device to be registered with BrainLab navigation systems and to be visible during a biopsy procedure. The Set also contains a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.
The BL Navigated Biopsy Needle and the predicated devices, the BrainLab Biopsy Needle Type A (K012564) and Medtronic Biopsy Needle (K971247), are based on the following same technological elements: material, construction, registration and tracking method and cutting actions. The table below summarizes the comparison of technological characteristics among the subject device and predicate devices.
| Technical Characteristics | Subject Device (K140705) | BrainLab Biopsy Needle Type A | Medtronic Biopsy Needle |
|---|---|---|---|
| Needle Material | Stainless steel | Stainless steel | Stainless steel |
| Biopsy Needle Construction | Inner and outer cannula | Inner and outer cannula | Inner and outer cannula |
| Biopsy Cutting Action | Side cutting | Side cutting | Side cutting |
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| window | window | window | |
|---|---|---|---|
| Registration and Tracking | |||
| method | retro-reflective | ||
| material | retro-reflective | ||
| material | retro-reflective | ||
| material | |||
| Needle Dimension (diameter) | 2.1 mm | 1.8 mm | 2.1 mm |
There are minor differences in needle dimension between the devices.
Summary of Performance Testing
Bench testing was conducted to demonstrate that the BL Navigated Biopsy Needle performs as intended and is substantially equivalent 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 and accuracy of the device with the specified navigation systems. Real-time shelf life testing was conducted to verify that there was no change in visual attributes, dimensional characteristics, or tensile strength after 5 years real time storage. These studies verify that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified above.
The biocompatibility evaluation for the BL Navigated Biopsy Needle was conducted in accordance with ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity and ANSI/AAMI ST72:2011 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. The battery of testing included the following tests:
- Cytotoxicity ●
- Pyrogen Testing
The patient contacting components of the Navigated Biopsy Needle are the outer and inner cannula. Patient contact time of the device is less than 24 hours. The outer and inner cannula are both made from AISI 304 stainless steel.
Summary
In summary, the non-clinical data support the safety of the device and the hardware verification and validation testing demonstrate that the IZI Navigated Biopsy Needle, used with BrainLab Vector Vision navigation system, should perform as intended in the specified use conditions.