Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet

K153709 · Devicor Medical Products, Inc. · KNW · Aug 8, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153709
• Device Name: Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
• Applicant: Devicor Medical Products, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Aug 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Mammotome elite® Biopsy System is intended to provide breast or axillary lymph node tissue samples for diagnostic analysis of imaged or palpated breast abnormalities.

Device Story

The Mammotome elite® Biopsy System is a handheld, vacuum-assisted biopsy device used under ultrasound guidance to collect breast or axillary lymph node tissue. It consists of a reusable electro-mechanical holster (containing a rechargeable lithium-polymer battery) and a single-patient-use sterile probe. The probe features a distal needle aperture and a proximal specimen collection cup. During operation, the holster generates a vacuum to draw tissue into the probe's aperture, while a high-speed rotating inner cutter translates to excise the tissue. The vacuum then transports the sample to the collection cup. Optional introducer stylets are available to assist in tissue penetration. The device is operated by clinicians in a clinical setting. The collected tissue is retrieved for histological examination to aid in the diagnosis of breast abnormalities. The system provides a minimally invasive method for obtaining diagnostic samples, potentially reducing the need for more invasive surgical procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing (biocompatibility per ISO 10993, electrical safety/EMC per IEC 60601-1/60601-1-2) and animal testing (in vivo porcine model). Animal studies validated tissue sample weight, transport reliability, and sample quality compared to the predicate. Bench testing evaluated force to penetrate. Results confirmed performance comparable to the predicate.

Technological Characteristics

Handheld, vacuum-assisted, electro-mechanical biopsy system. Materials: Stainless steel (needle/cutter), plastic (housing), elastomer/thermoplastic (sealing). Power: Rechargeable lithium-polymer battery. Connectivity: Standalone. Sterilization: Cobalt-60 irradiation. Software: Embedded firmware for battery charging and communication. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62366, ISO 10993.

Indications for Use

Indicated for obtaining tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. Intended for histologic examination via partial or complete removal of imaged abnormalities or partial removal of palpable abnormalities. Applicable to patients with palpable abnormalities classified as benign (e.g., fibroadenoma, fibrocystic lesion).

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Mammotome® elite Biopsy System (K112411)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2016

Devicor Medical Products, Inc. Ms. Shawna Rose Director, Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, OH 45241

Re: K153709

Trade/Device Name: Mammotome elite Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: July 8, 2016 Received: July 11, 2016

Dear Ms. Rose:

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

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CFR Part 807); labeling (21 CFR Part 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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 vours.

# Christopher J. Ronk -S

- For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K153709

Device Name Mammotome elite® Biopsy System

#### Indications for Use (Describe)

The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.

• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

· The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary - K153709

The following information is provided as required by 21 CFR § 807.92 for the Mammotome elite® Biopsy System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| General Provisions | Submitter Name: | Devicor® Medical Products, Inc. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Address: | 300 E-Business Way, Fifth Floor<br>45241 Cincinnati, OH |
| | Establishment Registration Number: | 3008492462 |
| | Contact Person: | Shawna Rose<br>Director, Regulatory Affairs |
| | Telephone Number: | 513-864-9178 |
| | Fax Number: | 513-864-9011 |
| | E-mail Address: | [e-mail] |
| | Date of Preparation: | December 21, 2015 |
| Subject Device | Trade Name: | Mammotome elite® Biopsy System |
| | Classification Name: | Instrument, Biopsy |
| | Regulation: | 21 CFR §876.1075 |
| | Product Code: | KNW |
| | Classification: | Class II |
| Predicate Device | Trade Name: | Mammotome® elite Biopsy System |
| | Classification Name: | Instrument, Biopsy |
| | Premarket Notification # | K112411 |
| | Manufacturer | Devicor® Medical Products, Inc. |
| Device Description | The Mammotome elite® Biopsy System consists of a reusable Holster (MEH1) and a<br>single-patient use, sterile Probe (MEP10 and MEP13) that is used with ultrasound<br>imaging guidance to excise and collect diagnostic samples with a single insertion of the<br>Probe. Introducer Stylets (MEI10 and MEI13) are also available as optional accessories<br>that can be used with the Mammotome elite® Biopsy System. The components of the<br>System are designed to operate safely when used together for diagnostic sampling of<br>tissue during a biopsy procedure. | |
| | The Holster is a self-contained, handheld, reusable electro-mechanical vacuum-assisted<br>biopsy device that consists of a rechargeable lithium-polymer battery and includes a<br>charging base with AC power adapter. The Probe consists of an outer trocar shaft, a<br>telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe<br>incorporates a distal needle aperture and a proximal specimen collection cup with a | |
| | body also contains two locking tabs to secure the Probe into the Holster. The Holster<br>creates vacuum inside the device to assist in pulling tissue into the aperture while the<br>sharpened inner cutter rotates at high speeds and extends across the aperture to<br>acquire targeted tissue. The tissue sample is transported by vacuum to the specimen<br>collection cup at the proximal end of the Probe. The integrated coaxial cannula may be<br>detached either after the biopsy and remain in the breast to retain a track to the biopsy<br>site when placing a biopsy site identifier or prior to the procedure when used in<br>conjunction with the Introducer Stylet. The Introducer Stylet/integrated coaxial<br>cannula combination is an option that is available for those physicians who are trained<br>in percutaneous needle techniques for tissue collection. | |
| Intended Use | The Mammotome elite® Biopsy System is intended to provide breast or axillary lymph<br>node tissue samples for diagnostic analysis of imaged or palpated breast abnormalities. | |
| Indications For<br>Use | The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the<br>breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.<br>In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. | |
| Performance<br>Tests | The following performance data were provided in support of the substantial<br>equivalence determination.<br>Biocompatibility Testing<br>The biocompatibility evaluation for the Mammotome elite® Biopsy System was<br>conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of<br>International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:<br>Evaluation and Testing,'" May 1, 1995, and International Standard ISO 10993-1<br>"Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a | |

tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe. The Probe

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Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- . Cytotoxicity
- Sensitization ●
- Irritation
- Systemic toxicity ●

The Mammotome elite® Biopsy System is considered tissue contacting for a duration of less than 24 hours.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Mammotome elite® Biopsy System, which consists of a reusable, rechargeable Holster, a single-patient use Probe (10G or 13G), and an optional single-patient use Introducer Stylet (MEI10 or MEI13). The system was tested in accordance to, and complies with, the applicable portions of the following electrical/electromagnetic standards:

#### Second Edition:

- IEC 60601 -1:1988 + A1:1991 + A2:1995
- · UL 60601-1:2003
- · CAN/CSA-C22.2 No. 601.1-M90
- EN 60601-1:1990 +A1+A2+A3
- · IEC 60601-1-2:2004

#### Third Edition:

- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007
- AAMI ES 60601-1:2005
- · CSA C22.2 No. 60601-1:2008
- EN 60601-1:2006
- · EN/IEC 60601-1-2:2007
- IEC 60601-1-6:2010
- · IEC 62366:2007

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of the hazards, a failure of the device Software could result in Minor Injury, either to a patient or to a user of the device.

### Animal Testing

Animal testing was conducted to validate the performance of the Mammotome elite® Biopsy System for acquisition of tissue, specifically for tissue sample weight, tissue transport reliability, and sample quality. An in vivo porcine animal model was used,

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which has historically been used to evaluate the ability for Mammotome biopsy devices for this purpose, and was used for both the predicate and proposed Mammotome elite® Biopsy Systems. All animal studies were conducted in compliance with 21 CFR Part 58, Good Laboratory Practices.

In these studies, acquisition of tissue samples from a single insertion site was evaluated against the following criteria and requirements:

- Tissue sample weight: The Mammotome elite® Biopsy System should acquire tissue sample weights that are comparable to the predicate device.
- . Tissue transport efficiency: The Mammotome elite® Biopsy System should deliver similar performance as the predicate system in terms of the percent of samples acquired to the number of samples attempted.
- Sample quality: The Mammotome elite® Biopsy System should not alter the characteristics of the acquired tissue in such a way as to affect the ability to achieve optimal histological assessment and is comparable to the predicate device.

Additionally, bench testing was done to evaluate force to penetrate for the Mammotome elite® Biopsy System compared to the predicate System.

The animal and bench testing results confirm that the Mammotome elite® Biopsy System performed comparable to that of the identified predicate device.

| Device<br>Comparison to<br>Predicate<br>Device | The Mammotome elite® Biopsy System, used with ultrasound imaging guidance, facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome elite® Biopsy System utilizes the same primary components as identified in the predicate device to achieve its intended use: a Probe, Holster, and Charging Base with AC power adapter.<br><br>The Mammotome elite® Biopsy System is identical to the predicate device in the following ways:<br>• Intended Use<br>• Indications for Use<br>• Target Population<br>• Fundamental Scientific Technology<br>• Operating Principles<br>• Driver Mechanical Design<br>• Performance Characteristics<br>• Product Requirements<br>• Packaging<br>• Sterility<br>• Biocompatibility |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| The subject device and the predicate device are different in the following ways: |
|-----------------------------------------------------------------------------------------------------------|
| • Addition of a 10G Probe (MEP10) |
| • Addition of a 10G (MEI10) and 13G (MEI13) Introducer Stylet |
| • Updates to the Holster (MEH1) battery configuration for increased performance<br>reliability |
| These changes provide more product offerings for physician preference and improved<br>system reliability. |

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| Table 1: Mammotome elite® Biopsy System Holster and Probe Side-by-Side<br>Comparison to Legally Marketed Device | | | |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristics | Marketed Device<br>Mammotome® elite<br>Biopsy System | Proposed Device<br>Mammotome elite®<br>Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Indications for Use | Breast Biopsy & Axillary<br>Lymph Nodes/<br>complete, partial<br>removal of imaged<br>abnormality/ partial<br>removal of palpated<br>abnormality | Breast Biopsy & Axillary<br>Lymph Nodes/<br>complete, partial<br>removal of imaged<br>abnormality/ partial<br>removal of palpated<br>abnormality | No change |
| Holster Assembly | | | |
| Mechanical Drive<br>Type | Onboard electrical<br>motors and drive train | Onboard electrical<br>motors and drive train | No change |
| Electrical Power<br>Source | Tetherless,<br>rechargeable, lithium<br>battery, charging base<br>with AC power adapter | Tetherless,<br>rechargeable, lithium<br>battery, charging base<br>with AC power adapter | No change |
| Vacuum | Self-contained,<br>reusable<br>electromechanically<br>created source | Self-contained,<br>reusable<br>electromechanically<br>created source | No change |
| Software Version | V. 2.70 | V.2.94.7.0 | Battery<br>charging and<br>communication<br>improvements |
| Firmware Version | V.2.92.3 | V.4.1.9 | Battery<br>charging and<br>communication<br>improvements |
| Probe Needle Subassembly | | | |
| Needle Insertion<br>Method | Manual | Manual | No change |
| Tip Type | Bladed trocar | Bladed trocar | No change |
| Tip Material | Stainless Steel | Stainless Steel | No change |
| Needle<br>Configuration | Single Lumen | Single Lumen | No change |
| Needle Material | Stainless Steel | Stainless Steel | No change |
| Sample Aperture<br>Configuration | Lateral Aperture | Lateral Aperture | No change |
| Needle Rotation<br>Method | Manual | Manual | No change |
| Device<br>Characteristics | Marketed Device<br>Mammotome® elite<br>Biopsy System | Proposed Device<br>Mammotome elite®<br>Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Probe Needle Dimensions | | | |
| Gauge | 13G | 13G, 10G | Addition of<br>Probe<br>(MEP10/10G) |
| Needle Length - tip<br>to Needle Rotation<br>Knob (mm) | 136mm | 136mm | No Change |
| Needle Length - Tip<br>to Coaxial Release<br>(mm) | 122mm | 122mm | No Change |
| Aperture Length<br>(mm) | 19.1mm | 19.1mm (13G),<br>18.4mm (10G) | Slight<br>difference due<br>to additional<br>gauge size |
| Tip length (mm) | 10.0mm | 10.0mm (13G),<br>10.4mm (10G) | Slight<br>difference due<br>to additional<br>gauge size |
| Probe Housing | | | |
| Specimen Retrieval<br>Method | Automatic | Automatic | No change |
| Housing Material | Plastic | Plastic | No change |
| Probe Cutter Subassembly | | | |
| Cutting Method | Rotation and<br>Translation of Inner<br>Cutter | Rotation and<br>Translation of Inner<br>Cutter | No change |
| Tissue Transport<br>Method | Vacuum | Vacuum | No change |
| Cutter Material | Stainless Steel | Stainless Steel | No change |
| Cutter Sealing<br>Mechanism | Yes | Yes | No change |
| Cutter Sealing<br>Material | Elastomer/Thermoplast<br>ic | Elastomer/Thermoplast<br>ic | No change |
| Site Marker Access | | | |
| Marking Method | Through Probe Coaxial<br>Cannula | Through Probe Coaxial<br>Cannula | No change |
| Sterilization (both Probe and Introducer Stylet) | | | |
| Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation | No change |
| Device<br>Characteristics | Marketed Device<br>Mammotome® elite<br>Biopsy System | Proposed Device<br>Mammotome elite®<br>Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Indications for Use | N/A | Breast Biopsy &<br>Axillary Lymph<br>Nodes/ complete,<br>partial removal of<br>imaged abnormality/<br>partial removal of<br>palpated abnormality | No change with<br>addition of<br>Introducer<br>Stylets |
| Introducer Needle Dimensions | | | |
| Gauge | N/A | 13G, 10G | Addition of Two<br>Introducer<br>Stylets<br>(MEI13/13G and<br>MEI10/10G) |
| Needle Length - tip<br>to Needle Rotation<br>Knob (mm) | N/A | 136mm | No Difference<br>between Probe<br>and Introducer<br>Stylet |
| Needle Length - Tip<br>to Coaxial Release<br>(mm) | N/A | 122mm | No Difference<br>between Probe<br>and Introducer<br>Stylet |
| Aperture Length<br>(mm) | N/A | N/A | No aperture as<br>not used for<br>tissue<br>acquisition; used<br>to aid in tissue<br>penetration |
| Tip length (mm) | N/A | 8.0mm (13G), 8.4mm<br>(10G) | Difference<br>between Probe<br>Needle Tip and<br>Introducer<br>Needle Tip due<br>to aperture…