ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

{0}------------------------------------------------ JUN 22 1998 ## 981166 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92(c)) - 1. INDICATIONS: The indications or intended use for the Inrad Accucore Biopsy Needle as well as the predicate device, Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897) are the same. Both have the same indications, which is for obtaining soft tissue biopsies with a commercially available biopsy instrument. Manan has the original 510K (K895897) which had an indication for prostate biopsy. In 1997 Manan was awarded a 510K for the same product with broader indications for liver, kidney and other soft tissues for diagnostic evaluation. - 2. DESIGN: The design of the Inrad Accucore Biopsy Needle as well as the predicate device is referenced in the Comparison Information Section. The products are identically manufactured using the identical manufacturing systems, design and materials. Both needles are manufactured by Manan Medical products, Inc. The primary difference is packaging and sterilization which will be performed by Inrad. - 3. MATERIALS: The device is manufactured from plastic(ABS) and stainless steel. The stainless steel is the only thing that has direct patient contact Both products are identically manufactured by Manan Medical Products Inc. using the identical manufacturing systems, design and materials - 4. SAFETY AND EFFECTIVENESS: Manan Medical Products Inc. has sold the identical device in the market place since 1989 and has proven to be safe and effective. The products are identically manufactured using the identical manufacturing systems, design and materials and there are no differences in safety and effectiveness. - 5. DIFFERENCES: There are no differences between the Inrad Inc. Accucore Biopsy Needle and the Manan Medical Products Inc. Core Biopsy Needle other than the source of packaging and sterilization. Inrad will be purchasing the identical product marketed by Manan, bulk and non-sterile, and then packaging and sterilizing the product using standard Inrad systems. Anne Armstrong Director Quality Assurance/Regulatory Affairs Inrad Incorporated 3956 44th St. SE Kentwood,MI 49512 Phone:(616) 554-7750 Ext. 102 Fax: (616) 554-7751 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three overlapping wings, symbolizing health, services, and the human aspect of the department's mission. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 22 1998 Ms. Anne Armstrong ·Director Ouality Assurance/Regulatory Affairs INRAD 3956 44th Street, S.E. Grand Rapids, Michigan 49512 Re: K981166 Trade Name: AccuCore Core Biopsy Needle Regulatory Class: II Product Code: KNW Dated: March 30, 1998 Received: March 31, 1998 Dear Ms. Armstrong: 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 vour 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. {2}------------------------------------------------ Page 2 - Ms. Anne Armstrong 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, Celia M. Witter, Ph.D., M.D. 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}------------------------------------------------ K991166 510 (k) Number (IF Known): Device Name: AccuCore Core Biopsy Needle Catalog Codes: 581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 Indications for Use: The Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use. (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) | <div style="text-align:center;">X</div> | |---------------------------------------|-----------------------------------------| |---------------------------------------|-----------------------------------------| OR | Over-The-Counter-Use (Optional Format 1-2-96) | | |-----------------------------------------------|--| |-----------------------------------------------|--| | (Division Sign-Off) | | |-----------------------------------------|----------| | Division of General Restorative Devices | | | 510(k) Number | 14981166 |