ECHO-COAT ULTRASOUND NEEDLES

{0}------------------------------------------------ K 983647 # 510(k) Summary # ECHO-COAT™ Ultrasound Needles Common/Classification Name: Manual Surgical Instrument, 21 CFR 878.4800 STS Biopolymers, Inc. 336 Summit Point Drive Henrietta, NY 14467 Contact: Michael Violante, Prepared: October 12, 1998 ### LEGALLY MARKETED PREDICATE DEVICES A. The ECHO-COAT™ Ultrasound Needles are substantially equivalent to the Disposable Chiba Biopsy Needle for Use with Ultrasound manufactured by Cook (K851957), as modified with the "EchoTip" for ultrasound imaging visibility. #### B. DEVICE DESCRIPTION STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name. #### C. INTENDED USE ECHO-COAT™ Ultrasound Needles are easily visualized on ultrasound images produced by currently available ultrasound imaging devices operating between 1 and 20 MHz. The needles are biocompatible when used according to their intended use. The specific indications for use for the needles purchased for coating will be assumed for the coated product. #### D. SUBSTANTIAL EQUIVALENCE SUMMARY The ECHO-COAT™ Ultrasound Needles have similar, but not identical, technological characteristics as the predicate devices. The 000022 . Ly {1}------------------------------------------------ could affect safety and effectiveness, e.g., the differences direronooo ooans of the polymer coating as compared to stainless blocomputibility of e o w characteristics do not raise new types of steen. However, and effectiveness questions and there are readily available Salety and offectively biocompatibility tests) to assess the effects of selections tools (significs (the material). STS is providing performance data to demonstrate equivalence where necessary. # TECHNOLOGICAL CHARACTERISTICS E. The needles that are purchased for coating by STS Biopolymers, Inc. The neoules that a same technological characteristics as the coated product that will be marketed by STS Biopolymers, Inc.. The additional product that will be coating is new, but it does not raise new types of safety and effectiveness questions. Biocompatibility is required of all needles and can be assured through testing using accepted standards. Ultrasound visibility is obtained through the new coating rather than by etching the surface as in the predicate device. However, there are readily available methods for determining ultrasound visibility also. Through the presentation of the resulting performance data, STS Biopolymers, Inc. has demonstrated that its proposed product is substantially equivalent to the predicate device. ## TESTING F. STS Biopolymers, Inc. carried out performance testing on the ECHO-COAT™ Ultrasound Needles. This testing addressed the following issues: - Sterilization (1) - (2) Package Integrity - Biocompatibility (3) - Imaging Performance Testing (4) All of the results demonstrate substantial equivalence. ## G. CONCLUSIONS This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. 000023 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 20 1999 T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 K983647 Re: Trade Name: ECHO-COAT™ Ultrasound Needle Regulatory Class: I Product Code: MJG Dated: October 16, 1998 Received: October 16, 1998 Dear Dr. Athey: We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your bootion by o(x) = (x) = (x) = (x) = (x) = = = = = indications for above and we have decembined avices marketed in interstate commerce prior to use stated in the enerosure) to actives he Medical Device Amendments, or to devices that May 20, 1970, the chaouncent auto of with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). " Tournaly, arefere) is provisions of the Act include requirements for provisions of the Free Frite genevices, 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 (1 remarket Approval), it they over can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I urs 600 to 699. In a facturing Practice requirement, as set forth in the Quality System Carrent Good Friend Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify through portodio (QD) inspecially with the GMP regulation may result in regulatory such assumptions. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does I oderal Negation you might have under sections 531 through 542 of the Act for not any other the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - T. Whit Athey, Ph.D. This letter will allow you to begin marketing your device as described in your 510(k) I mis letter witification. The FDA finding of substantial equivalence of your device to a prendared notificated 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, 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}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ ECHO-COATTM Ultrasound Needle Device Name: Indications For Use: The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) **Prescription Use** (Per 21 CFR 801/109) OR Over-The-Counter Use _ A coole Division Sign-Off