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.

Device Description

The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. The components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure. The Holster is a self-contained, handheld, reusable electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with 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 body also contains two locking tabs to secure the Probe into the Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.

AI/ML Overview

The Mammotome® elite Biopsy System is a biopsy instrument. The provided text describes the acceptance criteria and performance of the device based on a 510(k) submission (K112411).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Tissue sample weight	Comparable to identified predicate devices
Tissue transport reliability	Comparable to identified predicate devices
Sample quality	Comparable to identified predicate devices

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not explicitly state the sample size for the test set. It mentions "ex vivo and in vivo models" were used for side-by-side comparison.
Data Provenance: Not specified in terms of country of origin. The study involved both "ex vivo and in vivo models," suggesting a mix of laboratory (ex vivo) and potentially live subject (in vivo) testing. The document does not specify if the in vivo study involved human subjects or animal models. It does not indicate whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study focuses on comparing the device's ability to collect tissue samples against predicate devices, not on diagnostic accuracy requiring expert ground truth establishment for a test set.

4. Adjudication method for the test set

This information is not provided in the document. The study design, as described, does not appear to involve a diagnostic accuracy assessment that would necessitate an adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biopsy instrument, not an AI-powered diagnostic tool, so such a study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This device is a manual-use biopsy instrument with integrated software (firmware) for mechanical control, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing was based on the physical characteristics of the obtained tissue samples (weight, transport reliability, and quality) as compared to samples obtained using predicate devices. This implies an objective assessment of the tissue samples themselves, likely through established laboratory methods, rather than clinical outcomes or diagnostic accuracy requiring a ground truth like pathology for specific lesions.

8. The sample size for the training set

This information is not applicable/not provided. The device is a mechanical biopsy system with embedded firmware, not a machine learning model that requires a "training set" in the conventional AI sense. The software's function is to control the mechanical actions of the device, not to learn from data.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As mentioned above, the device does not involve a machine learning training set.

Summary

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510(k) Summary

The following information is provided as required by 21 CFR § 807.87 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.

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 18, 2011

Proprietary Name: Mammotome® elite Biopsy System

Common Name: Biopsy Instrument

Regulation: 21 CFR 876.1075

Regulatory Class: II

Product Codes: KNW

Predicate Device: Mammtome® EX Hand-Held System K033700; Bard Finesse™ Ultra Breast Biopsy System K093068.

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

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. 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 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.

Device Description: The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. The components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure. The Holster is a self-contained, handheld, reusable electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with 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 body also contains two locking tabs to secure the Probe into the Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.

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.

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Technological Characteristics:

The Mammotome® elite Biopsy System, used with or without imaging modalities, 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 predicate devices to achieve its intended use: a Probe and housing/Holster and control module componentry.

The Probe needle and cutter are similar in both the Mammotome®elite Biopsy System and predicate devices. The need for the stand alone control module in the predicate device (Mammotome® EX Hand Held System) has been removed through the miniaturization of the components now self-contained in the Mammotome® elite Biopsy System Holster. These physical changes make the Probe/Holster more ergonomic and facilitate ease of use by physicians.

Software was created and integrated into the device (firmware) to eliminate the need for a stand-alone control module and provide the Mammotome®elite Biopsy System the capability for cutter advancement and specimen retrieval, transport and harvesting.

Supplied vacuum is used in the harvesting and transporting of acquired tissue samples, obviating the need for the mechanical specimen transport.

Performance testing:

To demonstrate substantial equivalence of the proposed device to the two identified predicate devices, side-by-side comparison of tissue sample collection, using both ex vivo and in vivo models, was performed. These models have historically been used to evaluate the ability for Mammotome® breast biopsy devices to collect tissue samples.

The Mammotome elite Biopsy System and the two identified predicate devices were each used to obtain tissue sample was evaluated against the following criteria:

Tissue sample weight
. Tissue transport reliability
. Sample quality

Testing results confirmed that the Mammotome elite Biopsy System would retrieve a tissue sample comparable to that of the identified predicate devices.

Conclusion: The claim of substantial equivalence of the Mammotome® elite Biopsy System to the predicate devices is based on the comparison of the intended use, product technical characteristics, and performance characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

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

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

Re: K112411

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: March 9, 2012 Received: March 13, 2012

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 r read on 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 or any I edolar statutes and registered to including, but not limited to: registration and listing (21

MAR 2 0 2012

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Page 2 - Ms. Shawna M. Rose

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Nth cer 212

Mark N. Melkersoi Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K112411

Device Name: Mammotome® elite Biopsy System

Indications for Use:

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.

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 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.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mxm

Orthopedic,

10(k) Number K112411

Page 1 of 1

CONFIDENTIAL Page 28

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.