Mammotome revolve Dual Vacuum Assist Biopsy System

• K Number: K152989
• Device Name: Mammotome revolve Dual Vacuum Assist Biopsy System
• Manufacturer: DEVICOR MEDICAL PRODUCTS, INC.
• Date Cleared: 2016-02-25 ( 135 days)
• Product Code: KNW
• Regulation Number: 876.1075

Intended Use

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) 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 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 revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of 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.

Device Description

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination. The Mammotome revolve® Dual VAB System is comprised of three primary subsystems: - 1) a sterile, single-use probe - 2) a reusable holster, and - 3) a reusable control unit.

Predicate Devices

K033700, K123259

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical biopsy device and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device is primarily used for diagnostic sampling of breast abnormalities to obtain tissue samples for histologic examination, not for treating or curing a condition. While it can partially remove some benign lesions, its core function is diagnostic.

Diagnostic

Yes

The device is indicated to "provide tissue samples for diagnostic sampling of breast abnormalities for histologic examination," which directly supports its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electromechanical breast biopsy device" comprised of a sterile probe, reusable holster, and reusable control unit, all of which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use is to obtain tissue samples for diagnostic sampling and histologic examination. It is a device used to collect the sample, not to perform the diagnostic test on the sample itself.
• Device Description: The device is described as an electromechanical breast biopsy device comprised of a probe, holster, and control unit. This aligns with a device used for tissue collection.
• Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like tissue, blood, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is to acquire the specimen.
• Performance Studies: The performance studies focus on the ability of the device to collect tissue samples (sample weight, sampling reliability, sample quality), not on the diagnostic accuracy of analyzing those samples.

The tissue samples collected by the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System would then be sent to a laboratory for in vitro diagnostic testing (histologic examination). The Mammotome revolve® is the tool for obtaining the sample for that subsequent IVD testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) 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 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 revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of 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.

Product codes (comma separated list FDA assigned to the subject device)

KNW

Device Description

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.

The Mammotome revolve® Dual VAB System is comprised of three primary subsystems:

• 1. a sterile, single-use probe
• 2. a reusable holster, and
• 3. a reusable control unit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

The Mammotome revolve® Dual VAB System has been updated to integrate the Ultrasound modality as well as improvements on the performance reliability of the stereotactic functionality, while maintaining the basic technology, functionality and clinical outcomes of the predicate systems. Consistent with the configuration of the currently marketed systems, the Mammotome revolve® VAB System is configured for use in multiple imaging modalities, including Stereotactic and Ultrasound.

Anatomical Site

Breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

To demonstrate substantial equivalence of the proposed device to the predicate devices, sideby-side comparison of tissue sample collection, using an in vivo porcine model, was performed. This model has historically been used to evaluate the ability of Mammotome® biopsy devices to collect tissue samples.

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate devices were each used to obtain tissue samples. Each sample was evaluated against the following criteria:

• Sample weight
• Sampling reliability
• Sample quality

Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device.

Additional testing was performed as well for integration of Ultrasound functionality and system enhancements. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain test functionality and obtain tissue samples. Each sample was evaluated against the following criteria:

• . Sample weight
• . Sampling reliability
• Sample quality
• . Holster to Probe recognition
• . Holster/Control Module communication

Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device.

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.

Mammotome® Biopsy System, K033700, Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, K123259

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

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

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

February 25, 2016

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

Re: K152989

Trade/Device Name: Mammotome Revolve Dual Vacuum Assist Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: November 25, 2015 Received: November 27, 2015

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

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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" (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,

Jennifer R. Stevenson -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) K152989

Device Name

Device Name: Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System

Indications for Use (Describe)

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) 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 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 revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The following information is provided as required by 21 CFR § 807.92 for the Mammotome revolve® Vacuum Assisted Biopsy (VAB) 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.

Company:

Devicor® Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Establishment Registration Number: 3008492462

Contact:

Shawna Rose Director, Regulatory Affairs Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-864-9178 Fax: [phone] E-mail: [e-mail]

Date of Submission: November 24, 2015

Proprietary Name: Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System

Common Name: Biopsy System

Regulation: 21 CFR 876.1075

Regulatory Class: II

Product Codes: KNW

Classification Name: Biopsy Instrument

• Predicate Devices: Mammotome® Biopsy System, K033700 Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, K123259

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Device Description: The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.

The Mammotome revolve® Dual VAB System is comprised of three primary subsystems:

• 1. a sterile, single-use probe
• 2. a reusable holster, and
• 3. a reusable control unit.

Intended Use: The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• . The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
• The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) 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 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 revolve® Dual Vacuum Assisted Biopsy (VAB) 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.

Technological Characteristics:

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System utilizes the same primary subsystems as identified in the predicate devices to achieve its intended use:

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• 1. a sterile single use probe containing a trocar tipped biopsy needle, rotating cutter specimen, collection chambers and vacuum tubing/valving;
• 2. a reusable holster, containing the drive motors, gear trains and user activation switches; and
• 3. a reusable control unit, containing the vacuum pump, power supply, valve actuators, user interface touchscreen, control electronics, and software.

In addition, several optional accessories are available including remote keypad and footswitch controls, a transport cart, and probe guides for various stereotactic (ST) tables.

The Mammotome revolve® Dual VAB System has been updated to integrate the Ultrasound modality as well as improvements on the performance reliability of the stereotactic functionality, while maintaining the basic technology, functionality and clinical outcomes of the predicate systems. Consistent with the configuration of the currently marketed systems, the Mammotome revolve® VAB System is configured for use in multiple imaging modalities, including Stereotactic and Ultrasound.

The system relies on software to operate many of its functions including utilization of closed loop control on cutter position. In both predicate software systems, the focus of the software is to aid in system set-up and facilitate biopsy functions. The Mammotome revolve® Dual VAB System software has been updated to include the Ultrasound functionality, as well as to provide improved GUI screen functionality and address market feedback.

A side-by-side comparison of the marketed and proposed devices is provided below.

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Side-by-Side Comparison to Legally Marketed Device

Table 1a: Capital Equipment Side-by-Side Comparison of Mammotome revolve® Holster and Control Module to previous generation Mammotome® VAB Holster and Control Modules

| Device
Characteristics:
Holster / Control
Module | Marketed Device:
Mammotome® ST
System (K033700) | Marketed Device:
Mammotome® EX
System (K033700) | Marketed Device:
Mammotome revolve®
(ST) Biopsy System
(K123259) | Proposed Device:
Mammotome revolve®
(ST and U/S) Biopsy
System |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Breast Biopsy/complete,
partial removal of imaged
abnormality/ partial
removal of palpated
abnormality | Breast Biopsy/complete,
partial removal of imaged
abnormality/ partial
removal of palpated
abnormality | Breast Biopsy / complete,
partial removal of imaged
abnormality /partial
removal of palpated
abnormality | Breast Biopsy / complete,
partial removal of imaged
abnormality /partial
removal of palpated
abnormality |
| User interface
Mechanisms | Buttons on Remote Keypad,
Pedals on Footswitch,
Touchscreen | Buttons on Holster,
Buttons on Remote
Keypad, Pedals on
Footswitch, Touchscreen | Buttons on Holster, Buttons
on Remote Keypad, Pedals
on Footswitch, Touchscreen | Buttons on Holster, Buttons
on Remote Keypad, Pedals
on Footswitch, Touchscreen |
| Microprocessor and
upgradeable software | Yes | Yes | Yes | Yes |
| Display | Yes, LCD display | Yes, LCD display | Yes, LCD display | Yes, LCD display |
| Translational Cutter
Movement | Automatic or Semi
Automatic | Automatic or Semi
Automatic | Automatic | Automatic |
| Rotational Cutter
Movement | Automatic with cutter
advancement | Automatic with cutter
advancement | Automatic with cutter
advancement | Automatic with cutter
advancement |
| Rotational and
Translation Speed
control | Yes; Closed-loop control | Yes; Closed-loop control | Yes, Closed loop control | Yes, Closed loop control |
| Drive Train Type | Flexible Mechanical Drive
Cable | On board Motor and Gear
Train | On board Motor and Gear
Train | On board Motor and Gear
Train |
| Independent Lateral
and Axial Vacuum
System | Yes | Yes | Yes | Yes |
| Remote Footswitch /
Keypad Capability | Yes | Yes | Yes | Yes |

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510(k) Premarket Notification Mammotome revolve® Dual Vacuum Assisted Biopsy System

Disposables Side-by-Side Comparison of Mammotome revolve® Probes to Table 1b: previous generation Mammotome® VAB Probes

| Device Characteristics:
Probes | Marketed Device:
Mammotome® ST System
(K033700) | Marketed Device:
Mammotome® EX System
(K033700) | Marketed Device:
Mammotome revolve® (ST)
Biopsy System (K123259) | Proposed Device:
Mammotome revolve®
ST and U/S Biopsy System | | |
|-------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------|--|--|
| Needle Assembly | | | | | | |
| Needle Insertion
Method | Fired or Manual | Manual | Fired or Manual | Fired or Manual | | |
| Tip Type | Bladed trocar | Bladed trocar | Bladed trocar | Bladed trocar | | |
| Tip Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | |
| Needle Configuration | Dual lumen | Dual lumen | Dual lumen | Dual lumen | | |
| Needle Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | |
| Needle Diameter Sizes | 8G, 11G, and 14G | 8G, 11G, and 14G | 8G and 10G | 8G and 10G | | |
| Probe Housing | | | | | | |
| Vacuum Port
Attachment | Yes, tethered to control
module | Yes, tethered to control
module | Yes, tethered to Control
Module | Yes, tethered to Control
Module | | |
| Specimen Retrieval /
Collection Method | Manual | Manual | Automatic | Automatic | | |
| Housing Material | Plastic | Plastic | Plastic | Plastic | | |
| Probe Cutter Subassembly | | | | | | |
| Cutting Method | Rotation and translation of
inner cutter | Rotation and translation of
inner cutter | Rotation and translation of
inner cutter | Rotation and translation of
inner cutter | | |
| Tissue Transport
Method | Mechanical and Vacuum | Mechanical and Vacuum | Vacuum | Vacuum | | |
| Cutter Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | |
| Packaging | | | | | | |
| Type | C-film with Tyvek Cover | C-film with Tyvek Cover | PETG with Tyvek Cover | PETG with Tyvek Cover | | |
| Sterilization | | | | | | |
| Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation | Cobalt 60 Irradiation | Cobalt 60 Irradiation | | |

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Performance testing:

To demonstrate substantial equivalence of the proposed device to the predicate devices, sideby-side comparison of tissue sample collection, using an in vivo porcine model, was performed. This model has historically been used to evaluate the ability of Mammotome® biopsy devices to collect tissue samples.

The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate devices were each used to obtain tissue samples. Each sample was evaluated against the following criteria:

• Sample weight
• Sampling reliability
• Sample quality

Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device.

Additional testing was performed as well for integration of Ultrasound functionality and system enhancements. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain test functionality and obtain tissue samples. Each sample was evaluated against the following criteria:

• . Sample weight
• . Sampling reliability
• Sample quality
• . Holster to Probe recognition
• . Holster/Control Module communication

Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device.

Conclusion:

Side-by-side comparison of the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System to the predicate systems was performed on the technical characteristics of design, product components, materials of construction, system functionality, and clinical application (specifically, tissue sample characteristics). The test results of the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System demonstrated that it performed comparable to the safety and effectiveness of the predicate devices, and thus can be considered substantially equivalent.