AUTO SUTURE ABBI SYSTEM

{0}------------------------------------------------ # Auto Suture* ABBI* System K983296 SE 6-4-99 #### 510(k)_Summary of Safety and Effectiveness IX. United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 Christopher A. Graham CONTACT PERSON: June 4, 1999 DATE PREPARED: CI.ASSIFICATION NAME: Instrument, Biopsy Instrument, Biopsy COMMON NAME: Auto Suture* ABBI+ System PROPRIETARY NAME: Auto Suture* ABBI* System (K963825). PREDICATE DEVICES: The Auto Suture* ABBI* System uses stereotactic DEVICE DESCRIPTION: mammography to target non-palpable breast abnormalitics for biopsy. The system includes a disposable biopsy device, which uses a circular scalpel and elcctrocautcry snare to excise a diagnostic sample for diagnosis. To be used when stereotactically localized, large diameter, INTENDED USE: breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mainmographic abnormality that is suspicious for malignant disease (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. > The extent of a histologic abnormality cannot be appearance. mammographic determined from its Therefore, the extent of removal of a mammographic abnormality docs not predict the extent of removal of a histologic abnormality, c.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal. > The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis. {1}------------------------------------------------ ## Auto Suture* ABBI* System #### MATERIALS: All component materials of the Auto Suture* ABBI* System are comprised of materials which are in accordance with ISO Standard # 10993-1. CLINICAL SUMMARY: In a multi-centered, non-randomized, prospective study, 106 patients under went breast biopsy procedures using the Auto Suture* ABBI* System to evaluate the device for use in the removal of mammographic abnormalities. The Auto Suture* ABBI* System was evaluated on the following endpoints: - Primary endpoint: 106 of the 106 (100%) complete . procedures were successful for a histological diagnosis. 85 patients (80.2%) had benign lesions and 21 patients (19.8%) had malignant lesions. Of the 21 patients with malignant lesions, 7 (33.3%) had negative margins, 11 (52.4%) had positive margins, and 3 (14.3%) were undetermined. Consistent with the standard of care for excisional biopsies, all patients with malignancies were treated with a therapoutic modality after the diagnostic ABBI* procedure. - Secondary endpoint: 106 of the 106 (100%) . procedures were successful, in terms of removing a mammographically visible abnormality that had been radiographically marked for the purpose of diagnosis. 102 of the 106 (96.2%) procedures were completely removed, as verified by the presence of the Icsion in the specimen radiograph and by its absence in the patient's post-operative mammogram of the biopsy site. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes and a flowing tail. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 4 1999 Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856 Re: K983296 Trade Name: Auto Suture ABBI System Regulatory Class: II Product Code: KNW Dated: May 10, 1999 Received: May 12, 1999 Dear Mr. Graham: 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 - Mr. Christopher A. Graham 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, tocottefa 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}------------------------------------------------ IV. Indications For Use: 1 - - - - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 510(k) Number (if known): Name: Auto Suture* ABBI* System Indications For-Use: To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of a mammographic abnormality that is suspicious for malignant diseasc (i.e. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a mammographic abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically benign, it is essential that the tissue margins be examined for completeness of removal. The device is available in 5, 10, 15 and 20mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis. (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Evaluation (ODE) Prescription Use: OR Over-The-Counter Use: (Per 21 CFR §801.109) (Division Sign-Off) Division of General Restorative Devices K983296 510(k) Number 510(k) K983296 Additional Information May 20, 1999 United States Surgical * Trademark of United States Surgical ** Trademark name not yet determined Page 3 of 6