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
1. a reusable holster, and
1. a reusable control unit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, seeking to demonstrate its substantial equivalence to previously marketed devices. The study conducted focuses on comparing the new device with predicate devices in terms of tissue sample collection.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Evaluation Metrics)	Reported Device Performance
For Tissue Sample Collection Comparison:
Sample weight	"Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device."
Sampling reliability	"Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device."
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."
For Ultrasound Functionality and System Enhancements:
Sample weight	"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."
Sampling reliability	"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."
Sample quality	"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."
Holster to Probe recognition	"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."
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."

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

Sample Size: The document does not explicitly state the numerical sample size for the test set (i.e., the number of biopsy procedures or tissue samples collected). It mentions "each sample" was evaluated, implying multiple samples were taken.
Data Provenance: The study used an "in vivo porcine model." This indicates the data was collected from live pigs and is thus prospective animal data. The country of origin of the data is not specified.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. The evaluation criteria like "sample weight," "sampling reliability," and "sample quality" suggest objective measurements or potentially expert assessment, but the details are missing.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compared the device's performance against predicate devices, focusing on technical and functional aspects in an animal model, not on human reader performance with or without AI assistance. The device itself is a biopsy system, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the performance testing described effectively serves as a standalone evaluation of the device in an animal model. The device's ability to collect tissue samples based on specified criteria (weight, reliability, quality) and its functional aspects (holster/probe recognition, communication) were assessed independently of human interpretation of diagnostic output (which is the role of the pathologist reviewing the collected tissue).

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance seems to be based on objective measurements and qualitative assessment of physical samples. For example:
- "Sample weight" is a direct measurement.
- "Sampling reliability" and "sample quality" likely involve macroscopic and potentially microscopic assessment of the tissue collected, which could be considered a form of histological evaluation/pathology (though not explicitly stated as independent pathology reports).
- "Holster to Probe recognition" and "Holster/Control Module communication" are functional checks verified by the device's operational behavior.

8. Sample Size for the Training Set:

The document does not mention a training set. This is because the Mammotome revolve® Dual VAB System is a medical device for tissue collection, not an AI or machine learning algorithm that requires a training set for model development. The software mentioned primarily handles system operation and user interface, not diagnostic analysis requiring learning from data.

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

This question is not applicable as there is no mention of a training set for an AI/machine learning model.

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 (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,

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.

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: 513-864-9011 E-mail: srose@mammotome.com

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
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.

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;
1. a reusable holster, containing the drive motors, gear trains and user activation switches; and
1. 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

DeviceCharacteristics:Holster / ControlModule	Marketed Device:Mammotome® STSystem (K033700)	Marketed Device:Mammotome® EXSystem (K033700)	Marketed Device:Mammotome revolve®(ST) Biopsy System(K123259)	Proposed Device:Mammotome revolve®(ST and U/S) BiopsySystem
Indications for Use	Breast Biopsy/complete,partial removal of imagedabnormality/ partialremoval of palpatedabnormality	Breast Biopsy/complete,partial removal of imagedabnormality/ partialremoval of palpatedabnormality	Breast Biopsy / complete,partial removal of imagedabnormality /partialremoval of palpatedabnormality	Breast Biopsy / complete,partial removal of imagedabnormality /partialremoval of palpatedabnormality
User interfaceMechanisms	Buttons on Remote Keypad,Pedals on Footswitch,Touchscreen	Buttons on Holster,Buttons on RemoteKeypad, Pedals onFootswitch, Touchscreen	Buttons on Holster, Buttonson Remote Keypad, Pedalson Footswitch, Touchscreen	Buttons on Holster, Buttonson Remote Keypad, Pedalson Footswitch, Touchscreen
Microprocessor andupgradeable software	Yes	Yes	Yes	Yes
Display	Yes, LCD display	Yes, LCD display	Yes, LCD display	Yes, LCD display
Translational CutterMovement	Automatic or SemiAutomatic	Automatic or SemiAutomatic	Automatic	Automatic
Rotational CutterMovement	Automatic with cutteradvancement	Automatic with cutteradvancement	Automatic with cutteradvancement	Automatic with cutteradvancement
Rotational andTranslation Speedcontrol	Yes; Closed-loop control	Yes; Closed-loop control	Yes, Closed loop control	Yes, Closed loop control
Drive Train Type	Flexible Mechanical DriveCable	On board Motor and GearTrain	On board Motor and GearTrain	On board Motor and GearTrain
Independent Lateraland Axial VacuumSystem	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 InsertionMethod	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 PortAttachment	Yes, tethered to controlmodule	Yes, tethered to controlmodule	Yes, tethered to ControlModule	Yes, tethered to ControlModule
Specimen Retrieval /Collection Method	Manual	Manual	Automatic	Automatic
Housing Material	Plastic	Plastic	Plastic	Plastic
Probe Cutter Subassembly
Cutting Method	Rotation and translation ofinner cutter	Rotation and translation ofinner cutter	Rotation and translation ofinner cutter	Rotation and translation ofinner cutter
Tissue TransportMethod	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.

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.