MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,

{0}------------------------------------------------ # 991980 ### Section N ## Mammotome® Hand-Held System 510(k) Summary of Safety and Effectiveness #### Company Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242 #### Contact Tamima Itani, Ph.D. Director, Regulatory Affairs #### Date Prepared: June 11, 1999 #### Name of Device Trade Name: Mammotome® Hand-Held System Classification Name: Biopsy Needle #### Predicate Devices: Mammotome Biopsy Multi-Probe and Housing Powered Suction Pump Tubing Clamp and Tubing Accessory Arm Clamp #### Device Description The Mammotome® Hand-Held System is a mechanical breast biopsy device used in incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, and diffused tissue. The Mammotome® Hand-Held System consists of three major components, a disposable trocar tipped needle-like probe, a reusable holster/cable assembly, and a remote, reusable control module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a footswitch, a support arm and a cart. #### Intended Use The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multifocal disease, and diffused tissue. The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for therapeutic use. > Ethicon Endo-Surgery, Inc. Mammotome Hand-Held System 06/11/99 258 {1}------------------------------------------------ #### Technological Characteristics The Mammotome® Hand-Held System is a modification of the currently marketed Mammotome Biopsy System. While it represents a refinement over the first generation Mammotome with design, software and ergonomic enhancements for ease of use, the overall configuration, technology, materials and principles of operation of the proposed and marketed devices are equivalent. The hand-held biopsy device, used with or without imaging modalities, provides for the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting functions. The proposed and marketed devices contain the same primary components to achieve these functions: a probe, housing/holster, and a control module. The probe needle and cutter, which interface directly with the patient, are identical in both new and marketed devices. In the proposed device, the housing is replaced by a holster and cable assembly and the motor resides in the control module. These physical changes make the probe lighter and more portable and facilitate user and patient interface. The addition of a microprocessor and software allows the Mammotome® Hand-Held System to provide semi-automatic and automatic modes of operation for cutter advancement, vacuum, and specimen retrieval. Microprocessor control also provides closed-loop control to reduce dependence of cutter rotation and translation speed on user interaction or tissue variability. In the marketed device, axial and lateral vacuum cannot be independently controlled. In the new device, axial and lateral vacuum can be controlled independently. #### Performance Data Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 17 1999 Tamima Itani, Ph.D., RAC Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242 K991980 Re: > Trade Name: Mammotome® Hand-Held System Regulatory Class: II Product Code: KNW Dated: June 11, 1999 Received: June 14, 1999 Dear Dr. Itani: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ #### Page 2 - Tamima Itani, Ph.D., RAC This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Russell U. Ayers - Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement 510(k) Number: K_991980 Device Name: Mammotome® Hand-Held System Indication for Use: The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multifocal disease, and diffused tissue. The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for 。 therapeutic use. Russell W. Rayner Jr. (Division Sign-Off) Division of General Restora 510(k) Number . Prescription Use (Per 21 CFR 801.109)