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.

Device Description

The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is a mechanical 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
1. a reusable holster, and
1. a reusable control unit.

AI/ML Overview

This submission describes the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System, a mechanical breast biopsy device designed to obtain tissue samples for diagnostic sampling of breast abnormalities. The device is an updated version of the predicate device, the Mammotome® Biopsy System (K033700), with improvements aimed at enhancing efficiency and ease of use while maintaining core technology and clinical outcomes.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Sample weight	Comparable to predicate device
Sampling reliability	Comparable to predicate device
Sample quality	Comparable to predicate device

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The text mentions "side-by-side comparison of tissue sample collection."
Data Provenance: In vivo porcine model. This indicates the testing was conducted on live animals, not human subjects, and is considered prospective for the purposes of this study as it was performed specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. The study used an in vivo porcine model and evaluated performance based on sample characteristics (weight, reliability, quality) rather than diagnostic accuracy against a human expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was a performance comparison study in an animal model, not a diagnostic accuracy study requiring adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This submission is for a medical device (biopsy system), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related improvement metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a mechanical biopsy device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth was established by comparing the tissue samples obtained by the proposed device to those obtained by the predicate device based on objective measures of sample weight, sampling reliability, and sample quality. These are direct physical sample characteristics, not a diagnostic "ground truth" in the traditional sense of disease presence/absence.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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510(k) Premarket Notification Mammotome® revolve Dual Vacuum Assisted Biopsy System Devicor Medical Products, Inc. August 13, 2012

K 123259

510(k) Summary

NOV 1 5 2012

The following information is provided as required by 21 CFR § 807.87 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: 513-864-9011 E-mail: srose@mammotome.com

Date of Submission: August 13, 2012

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 Device: Mammotome® Biopsy System, K033700

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

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K123259 2/6

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

1. a sterile, single-use probe
1. a reusable holster, and
1. 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 device to achieve its intended use:

a sterile single-use probe containing trocar tipped biopsy needle, rotating cutter, 1) specimen collection chambers, and vacuum tubing/valving which enables tissue sample

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123259

acquisition under vacuum, tissue cutting, and tissue transport to the specimen collection chambers;

3/6

1. a reusable holster containing the drive motors, gear trains and user activation switches, which provides the basic functionality for the procedure including the rotation, advancement and retraction of the cutting mechanism of the probe, as well as the specimen management system rotation; and
1. a reusable control unit that houses the vacuum pump, power supply, valve actuators, software, user interface touchscreen and control electronics, which provides the primary electrical, electronic, mechanical and vacuum control of the system.

In addition, several 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 is an updated version of the currently marketed system, incorporating changes to improve efficiency and ease of use, while maintaining the basic technology, functionality and clinical outcomes of the predicate system. Consistent with the configuration of the currently marketed system, the Mammotome® revolve VAB System will be configured for use in multiple imaging modalities, including Stereotactic, Ultrasound, Magnetic Resonance and Advanced Molecular Imaging.

The system relies on software to operate many of its functions including utilization of closed loop control on cutter position. As with the predicate system, 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 simplify the touch screen display used to set up the system and create a single button push Biopsy function that transports the tissue sample back to a collection system for retrieval and analysis.

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

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123259 416

Side-by-Side Comparison to Legally Marketed Device

Device Characteristics	Marketed Device Mammotome® STSystem	Proposed Device Mammotome®revolve Biopsy System
Indications for Use	Breast Biopsy/complete, partialremoval of imaged abnormality/partialremoval of palpated abnormality	Breast Biopsy / complete, partialremoval of imaged abnormality/partialremoval of palpated abnormality
Needle Assembly
Needle Insertion Method	Fired or Manual	Fired or Manual
Tip Type	Bladed trocar	Bladed trocar
Tip Material	Stainless steel	Stainless steel
Needle Configuration	Dual lumen	Dual lumen
Needle Material	Stainless steel	Stainless steel
Sample ApertureConfiguration	Lateral aperture in needle	Lateral aperture in needle
Needle Diameter Sizes	8G, 11G, and 14G	8 G & 10 G
Needle Rotation Method	Manual, Remote Thumbwheel	Manual, Remote Thumbwheel
Probe Housing
Vacuum PortAttachment (ValveCartridge)	Yes, tethered to control module	Yes, tethered to Control Module
Specimen Retrieval /Collection Method	Manual	Automatic
Housing Material	Plastic	Plastic
Probe Cutter Subassembly
Cutting Method	Rotation and translation of inner cutter	Rotation and translation of inner cutter
Tissue Transport Method	Mechanical and Vacuum	Vacuum
Cutter Material	Stainless steel	Stainless steel
Cutter SealingMechanism	Yes	Yes
Cutter Sealing Material	Elastomer/Thermoplastic	Elastomer/Thermoplastic
Knockout Sub Assembly
Knockout Material	Stainless steel
Knockout SealingMechanism	Yes	No Knockout / Specimen Retrieval
Knockout SealingMaterial	Elastomer/Thermoplastic	Automatic
Fluid Injection Capability	Yes
Packaging
Type	C-film with Tyvek Cover	PETG with Tyvek Cover
Device Characteristics	Marketed Device Mammotome® ST System	Proposed Device Mammotome® revolve Biopsy System
Marking Access	Through Needle	Through Device
Sterilization
Method	Cobalt 60 Irradiation	Cobalt 60 Irradiation
Tubing Set
Physical Properties
Tubing Material	PVC	PVC with no DEHP
Features
Attachment to Probe	Luer	Luer
Attachment to control Module	Cartridge with two parallel vacuum lines leading to probe	Cartridge with two parallel vacuum lines leading to probe + Saline line leading to probe
Vacuum Control	Solenoid activated stopcocks	Motor activated Rotary Valves
Sterilization
Method	Cobalt 60 Irradiation	Cobalt 60 Irradiation
Holster/Cables / Control Module
Features
User interface Mechanisms	Buttons on holster, Pedals on Footswitch or Touchscreen	Buttons on holster, Footswitch Pedals, Touchscreen, Keypad
Microprocessor and software with Upgrade Capabilities	Yes	Yes
Display	Yes, LCD display	Yes, LCD display
Translational Cutter Movement	Automatic or Semi Automatic	Automatic
Rotational Cutter Movement	Automatic with cutter advancement	Automatic with cutter advancement
Rotational and Translation Speed control	Yes; Closed-loop control	Yes, Closed loop control
Automated Initialization of Disposable Probe	Yes	Yes
Probe firing capability	Yes	Yes
Motor location	Control Module	Holster
Drive Train Type	Flexible Mechanical Drive Cable	On board Motor and Gear Train
Independent Lateral and Axial Vacuum System	Yes	Yes
Remote Footswitch/Keypad Capability	Yes	Yes

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

Assisted Biopsy System
K123259 5/6

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510(k) Premarket Notification Mammotome® revolve Dual Vacuum Assisted Biopsy System Devicor Medical Products, Inc. August 13, 2012

K123259 6/6

Performance testing:

To demonstrate substantial equivalence of the proposed device to the predicate device, 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 for Mammotome® breast biopsy devices to collect tissue samples.

The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain tissue 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.

Conclusion: The claim of substantial equivalence of the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System to the predicate system is based on the comparison of the intended use, product technical characteristics, and performance characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments, representing health, human services, and the partnership between the federal government and the states. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 15, 2012

Underwriters Laboratories, Incorporated % Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook Road, Illinois 60062

Re: K123259

Trade/Device Name: Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 16, 2012 Received: October 18, 2012

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Ned Devine

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K 123259

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

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of Device Evaluation (ODE)
I, Orthopedic, (Division Sign-Off Division of Surgical and Restorative Devices

510(k) Number 23,255

ين Page 5-2

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.