AUTO SUTURE* ILM** KIT

{0} K971201 # ENCLOSURE I ## 510(k) SUMMARY AND SAFETY AND EFFECTIVENESS JUN - 3 1997 **SUBMITTER:** United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 **CONTACT PERSON:** Victor Clavelli **DATE PREPARED:** May 21, 1997 **CLASSIFICATION:** Procedure Kit **COMMON NAME:** Lymphatic Mapping Kit **PROPRIETARY NAME:** Not yet determined **PREDICATE DEVICES:** AUTO SUTURE* Premium SURGICLIP* Standard Hyperdermic Needle Standard Syringe with LuerLock Standard Sterile Marking Pen Standard Surgical Ruler DRUG-Lymphazurin Blue **KIT DESCRIPTION:** The Kit consists of 5 devices and a drug (see predicate device list) which are packaged together in accordance with their existing labeling and indications for use in lymphatic mapping procedures. **INTENDED USE:** The AUTO SUTURE* ILM** Procedure Kit has application in the surgical mapping of the lymphatic system. **MATERIALS:** All of the device contained within this kit are currently marketed instruments which are composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Victor Clavelli Senior Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856 Re: K971201 Trade Name: Auto Suture* ILM** Kit Regulatory Class: Class II Product Code: FZP Dated: March 31, 1997 Received: April 1, 1997 JUN - 3 1997 Dear Mr. Clavelli: 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your {2} Page 2 - Mr. Victor Clavelli 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. In addition, we have determined that your device kit contains Lymphazurin which is subject to regulation as a drug. Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact: Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063 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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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,  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 {3} K971201 # ENCLOSURE II ## INDICATIONS FOR USE 510(k) Number (if known): K971201 **Device Name:** AUTO SUTURE* ILM** Procedure Kit **Indications For Use:** The AUTO SUTURE* ILM** Procedure Kit is indicated for use in lymphatic mapping. (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)  Prescription Use: ☑ OR Over-The-Counter Use: (Per 21 CFR 801.109)