SECURCUT ASPIRATION BIOPSY NEEDLE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters "HG" in a bold, stylized font. The letters are interconnected and have a textured, pixelated appearance, giving them a retro or digital feel. The overall design is simple yet eye-catching, with a focus on the interplay between the two letters. ## PREMARKET NOTIFICATION SUBMISSION - 510 (k) Pag. 35 di 36 # KO13071 ## 510 (k) SUMMARY DEC 1 2 2001 | Applicant | : H.S. Hospital Service S.p.A.<br>Via Naro, 81 - 00040 Pomezia (RM) Italy | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | : MMC International, LLC<br>Mr. Lucio Improta<br>10147 Umberland Place - Boca Raton, FL 33428<br>Tel. (561) 477-1671 - Fax. (561) 477-0863<br>e-mail : mmcintern@aol.com | | Submission Date | : September 03, 2001 | | Trade Name | : SecurcutTM Aspiration Biopsy Needle | | Common Name | : Aspiration Biopsy Needle | | Classification Name | : 876.1075 - Biopsy instrument | #### Indication for use : This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three abstract birds in flight, arranged in a row. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 2 2001 H.S. Hospital Service S.p.A. c/o Mr. Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428 Re: K013071 Trade/Device Name: Securcut™ Aspiration Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: September 3, 2001 Received: September 13, 2001 #### Dear Mr. Improta: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to oonimoted pror to Trad 20, 20, 2017 ) devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrosere, mans of the Act include requirements for annual registration, listing of general oonline provision practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 70at ab 100 is o such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. Lucio Improta This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaited 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of adultionally 21 211) 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O wision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Walker Image /page/2/Picture/5 description: The image shows a handwritten signature. The signature is in black ink and appears to be cursive. The signature is short and illegible. Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the letters "JPC" in a bold, sans-serif font. The letters are stacked on top of each other, with the "J" and "P" on the top line and the "C" on the bottom line. The letters are black and the background is white. The logo has a pixelated appearance. ### PREMARKET NOTIFICATION SUBMISSION - 510 (k) ## 510 (k) # KO13071 DEVICE NAME Securcut™ Biopsy Needle #### INDICATION FOR USE This device is intended to be used for taking biopsy sample, must be used on soft tissues and I his device is intended to be used to taxing brops, bann biopsies of various tissues, can be tised in Fraoroscopic, CF and mananegraphias provide, Abdomen and Pancreas PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED PLEASE DO NOT WATE DELOW THIP ENAE CONTINER CONTINER CONTENTIAL CONTENTERS --------------------------------------------------------------------------------------------------- Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Walker (Division Sign-Off) (Division Bigi-eral, Restorative Divisionrological Devices 510(k) Number k013071 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use