BIOSUC

{0}------------------------------------------------ K013108 1/: HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax 81-(3)-464-8539 APR 0 4 2002 Contact person: M. Moruyama 2. DEVICE NAME Proprietary Name(s): BioSuc Common Name(s): Fine Aspiration Cytology Needle Device Class: Class II 21CFR 876.1075 Aspiration biopsy needle (gastroenterology-urology biopsy instrument). Product Code: KNW ### 3. STATEMENT OF SUBSTANTIAL EQUIVALENCE: Predicate Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Allegiance Aspiration Needle K831392 Travenol Lab. Daum Aspiration Biopsy Needle K974575 Daum GMBH The Biosuc Fine Aspiration Cytology Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use. ### 4. DESCRIPTION OF THE DEVICE(S) Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: 0 0.35 to 0 0.5 n=0 to 3 21G: φ 0.35 to φ 0.5 n=0 to 3 22G: ф 0.35 n=0 to 2 | Product Code No. | Needle size | Side Hole | Syringe | |------------------|-------------|----------------------|---------| | 22030500 | 20Gx50mm | \$\phi\$ 0.5 1 hole | 7 ml | | 22030510 | 20Gx100mm | \$\phi\$ 0.5 1 hole | 7 ml | | 22030520 | 21Gx50mm | \$\phi\$ 0.5 1 hole | 7 ml | | 22030540 | 22Gx50mm | \$\phi\$ 0.35 1 hole | 7 ml | 5. STATEMENT OF INTENDED USE: Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface. {1}------------------------------------------------ # K013108 2/2 - DESCRIPTION OF DEVICE(s): E. DESORIE: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: φ 0.35 to φ 0.5 n=0 to 3 21G: φ 0.35 to φ 0.5 n=0 to 3 22G: φ 0.35 n=0 to 2 | Product Code No. | Needle size | Side Hole | Syringe | |------------------|-------------|---------------|---------| | 22030500 | 20Gx50mm | φ 0.5 1 hole | 7 ml | | 22030510 | 20Gx100mm | φ 0.5 1 hole | 7 ml | | 22030520 | 21Gx50mm | φ 0.5 1 hole | 7 ml | | 22030540 | 22Gx50mm | φ 0.35 1 hole | 7 ml | - PROPOSED LABELING: F. See attached (Page 46) Each Product Label will have the following information: Complete product description Manufactured by: Hakko Medical Co., Ltd. Distributed by: Havel's Incorporated 3726 Lonsdale Street Cincinnati, Oh 45227 (513) 271-2117 Made in Japan #### SINGLE USE ONLY STERILE CAUTION: Do not use if package has been opened or damaged. Store in a cool, dry place. Federal law restricts this device to sale by or on the order of a physician. Sterile unless opened or damaged - STATEMENT OF INTENDED USE: G. Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES 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 image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Hakko Medical Company, Ltd. c/o Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome Meguro-Ku, Tokyo, Japan 153 ## APR 0 4 2002 Re: K013108 Trade/Device Name: BioSuc Fine Aspiration Cytology Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 14, 2001 Received: March 21, 2002 Dear Mr. Kitagawa: We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we have reviewed your Section 510(x) premained 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 cherosure) to regary many of the Medical Device American by the debecal Brush Brush commerce provided in accordance with the provisions of the Federal Food, Drug, devices that have bech recadssince in acce approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the recess, 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 If your device is classince (see above) into existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations FRA this be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of I cases oncerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or wouldwice complies with other requirements of the Act that IDA has made a acterimations administered by other Federal agencies. You must or any if ederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, me. and 801); good manufacturing practice requirements as set CFN Fatt 807), labeling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ### Page 2 - Mr. Shiro Kitagawa This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w Jourse FDA finding of substantial equivalence of your device to a legally premative notification "The 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 11 you desire by of CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0071 or questions on the promotion and advertising of Comphance at (301) 594-1697 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisolanany responsibilities under the Act may be obtained from the Outer general information of you 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, Miriam C. Provost for 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 {4}------------------------------------------------ 510(k) Number (if known): KO(3108 Device Name Big Suc Firme Aspination Cutology Needle Indications For Use: The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrente of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use Poplional Formar 1-2-96) Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K013108