SONOPSY

{0}------------------------------------------------ # 510(K) SUMMARY - HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax 81-(3)-464-8539 Contact person: M. Moruyama - 2. DEVICE NAME SONOPSY Proprietary Name(s): Aspiration biopsy needle Common Name(s): Classification: Aspiration biopsy needle (gastroenterology-urology biopsy instrument). 21CFR 876.1075 Class II Product Code: FCG #### STATEMENT OF SUBSTANTIAL EQUIVALENCE: 3. Predicate Device: | INRAD/MANAM | Accucore Biopsy Needle | K981166 | |--------------|--------------------------|---------| | E-Z-EM, INC. | Lufkin Aspiration Needle | K882601 | | DAUM Corp. | DAUM AspirationNeedle | K974575 | The Sonopsy Aspiration Biopsy Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use. #### DESCRIPTION OF THE DEVICE(S): 4. Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces | Product<br>Code No. | Needle size | Needle<br>tip | Inner<br>needle<br>tip | Syringe | Guide<br>needle size | Guide needle<br>tip | Filter<br>paper | |---------------------|-------------|-----------------|------------------------|---------|----------------------|---------------------|-------------------| | 22032170 | 21Gx170mm | Biopsy<br>point | Pencil<br>point | 7 ml | 18Gx70mm | Lancet point | 20x35<br>3 pieces | | 22032180 | 21Gx180mm | Biopsy<br>point | Pencil<br>point | 7 ml | 18Gx70mm | Lancet point | 20x35<br>3 pieces | #### న. STATEMENT OF INDENDED USE The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 1 2 2002 Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome, Meguro-ku, Tokyo 153 JAPAN Re: K013109 Trade/Device Name: HAKKO Sonopsy Biopsy Needle Set Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: December 21, 2001 Received: December 26, 2001 Dear Mr. Kitagawa We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), it may be subject to 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Other or Compilance w ( rotification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ KOT 370 ## 510(k)NUMBER (IF KNOWN) K013109 DEVICE NAME: Aspiration Biopsy Needle ### INDICATION FOR USE: The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization. David C. Byrom (Division Sign-Om 4 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number KOB109 (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 CFE 801.109) OR Over-The-Counter-Use (Options Format 1-2-9