MAMMOTOME ELITE BIOPSY SYSTEM

{0}------------------------------------------------ # MAR 2 0 2012 # 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. {1}------------------------------------------------ - . 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. {2}------------------------------------------------ ## 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ ## 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. 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 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