MANAN ACCURA NEEDLE

{0}------------------------------------------------ **AAD** ## K974741 4445-310 S.W. 35th Terra Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 ## 510(k) SUMMARY JAN - 8 1998 | APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 | | |--------------------------|----------------------------------------------------------------------------------------|-----------| | CONTACT: | Karl Swartz<br>Quality Assurance Manager | | | TELEPHONE: | (352)338-0440<br>fax (352)338-0662 | | | TRADE NAMES: | Manan™ Accura Needle | | | COMMON NAME: | Spring hook localization needle | | | CLASSIFICATION NAME: | Needle, Aspiration and Injection, Disposable - 79GAA | | | SUBSTANTIAL EQUIVALENCE: | | | | Company Name | Product Name | 510(k) No | | Manan Medical Products | Accura needle | K863848 | ## DESCRIPTION OF DEVICE: This needle is made in various gauges from 20 to 21 ga, and in various lengths from 3 to 15 cm. It is composed of an outer cannula essentially identical to the standard hypodermic needle and an inner stylet spring wire with an overbent tip. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Karl Swartz Ouality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainsville, Florida 32608 Re: K974741 Trade Name: Manan™ Accura Needle Regulatory Class: I Product Code: GAA Dated: December 17, 1997 Received: December 19, 1997 Dear Mr. Swartz: 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 requirements , as set forth in the Quality System -Regulation (OS) 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 JAN - 8 1908 {2}------------------------------------------------ Page 2 - Mr. Swartz 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. 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 {3}------------------------------------------------ Image /page/3/Figure/0 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. Below the letters, there are three horizontal lines. The logo is white and is set against a black background. The overall design is simple and modern. 445-310 S.W. 35th Te Gainesville, Florida 3260 TEL: 352/338-0440 FAX: 352/338-0662 Page_1_of_1_ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Manan™ Accura Needle . . Indications for Use: The Manan™ Accura needle is intended for use as a needle localization of breast lesions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) bcolfe (Division Sign-Off) Division of General Restorative Devices K97474) 510(k) Number_ Prescription Use_ (Per 21 CFR.801 109) . . OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)