MDT Navigable Brain Biopsy Cannula

K143241 · Izi Medical Products, LLC · HAW · Apr 13, 2015 · Neurology

Device Facts

• Record ID: K143241
• Device Name: MDT Navigable Brain Biopsy Cannula
• Applicant: Izi Medical Products, LLC
• Product Code: HAW · Neurology
• Decision Date: Apr 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

Device is a pre-sterilized, single-use, stainless steel side-cutting cannula for stereotaxic cranial tissue biopsy. Input: manual operation by trained healthcare professional in healthcare facility. Operation: inner cannula rotates within outer cannula to excise tissue via side-cutting window. Navigation: device features retro-reflective elements for registration and visualization with Medtronic StealthStation® Image Guided Surgery System. Output: tissue sample for diagnostic analysis. Benefit: enables precise, image-guided tissue sampling for cranial biopsies.

Clinical Evidence

Bench testing only. Testing included tissue extraction verification to confirm sampling capability and navigation testing to verify compatibility with Medtronic StealthStation® IGS systems. No clinical data provided.

Technological Characteristics

Materials: Stainless steel (AISI 304) cannula, plastic hub. Features: Side-cutting window, retro-reflective elements for IGS registration. Dimensions: 2.1 mm diameter. Energy: Manual. Connectivity: Passive optical tracking via IGS system. Sterilization: Pre-sterilized, single-use.

Indications for Use

Indicated for patients undergoing stereotaxic brain biopsy procedures.

Regulatory Classification

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.

Predicate Devices

• Medtronic Biopsy Needle (K971247)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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: [phone] Fax: [phone]

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<br>Characteristics | Subject Device<br>(K143241) | Medtronic Biopsy Needle<br>(K971247) | Comparison |
|---------------------------------------|-----------------------------|--------------------------------------|------------|
| Needle/Cannula<br>Material | Stainless steel (AISI 304) | Stainless steel (AISI 304) | Identical |
| Biopsy Needle/Cannula<br>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<br>Tracking Method | Retro-reflective material | Retro-reflective material | Identical |
|-------------------------------------|------------------------------|---------------------------|-----------|
| Compatible IGS | Medtronic<br>StealthStation® | Medtronic StealthStation® | Identical |
| Needle Dimension<br>(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.