ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc. The logo consists of a circular graphic on the left, followed by the text "ETHICON ENDO-SURGERY, INC." on the right. Below the text is the phrase "a Johnson & Johnson company" in a smaller, cursive font. Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '994280'. The characters are written in black ink on a white background. The handwriting appears somewhat cursive, with the numbers connected to each other. MAR 1 7 2000 4545 CREEK ROAD CINCINNATI, OH 45242-2839 ## SUMMARY OF SAFETY AND EFFECTIVENESS #### COMPANY: Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 ### CONTACT: Ruth Ann Wood Senior Regulatory Affairs Associate Telephone: 513/337-3468 FAX: 513/337-8539 #### DATE PREPARED: December 17, 1999 #### NAME OF THE DEVICE and CLASSIFICATION: Trade Name: UltraCision Harmonic Scalpel Sharp Curved Blade Classification: LFL #### PREDICATE DEVICES: UltraCision Harmonic Scalpel Curved Blades, Sharp Hook Blades and Dissecting Hook Blades ## DEVICE DESCRIPTION: The UltraCision instruments are hand-held instruments which cut and coagulate soft tissue when attached to the ultrasonic hand piece and generator. {1}------------------------------------------------ ## INTENDED USE: These instruments are indicated for soft tissue indications when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecologic, and thoracic surgery. # TECHNOLOGICAL CHARACTERIZATION: The technological characteristics of the Sharp Curved Blade are the same as the predicate devices. Ultrasonic technology is the method of activation. The Sharp Curved blades are constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for the intended contact profile. ## PERFORMANCE DATA: Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation. {2}------------------------------------------------ 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 stylized eagle or bird symbol, with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Public Health Service MAR 1 7 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839 Re: K994280 Trade Name: UltraCision® Harmonic Scalpel® Sharp Curved Blade Regulatory Class: II Product Code: LFL Dated: December 17, 1999 Received: December 20, 1999 Dear Ms. Wood: 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 control provisions of the Act. The general control 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. 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. {3}------------------------------------------------ Page 2 - Ms. Ruth Ann Wood 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) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Stypk Rhodes 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}------------------------------------------------ Page ਨ DEVICE NAME : INDICATIONS FOR USE: The UltraCision Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for allemming ty, lasers, and steel scalpels in general, gynecologic, and thoracic surgery. Stat Rwordr (Division Sign-Off) Division of General Restors 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE Prescription Use X (Per 21 CFR 801.109) OR ・. Over-The-Counter (Optional Form