SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300

{0}------------------------------------------------ Page (1) 8 E ## 5. 510(K) SUMMARY ## DISPOSABLE SHINMED various models of Electro-Surgical Pencils, Models: SW12200, SW12202, SW12300 # 210K: KO33027 . | Submitted by: | SHINING WORLD HEALTH CARE CO., LTD. | | | |------------------------------|---------------------------------------------------------------------------------|--|--| | | 6F, No.8, Lane 7, Wu-Chun Road, Wu-Ku Industrial | | | | | Park, Taipei, China (Taiwan) | | | | Contact person: | Dr. Jen, Ke-Min | | | | | No.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, R.O.C | | | | | Tel: 886-3-5208829 fax: 886-3-5209783 | | | | | E-mail: ceirs.jen@msa.hinet net | | | | Date Summary Prepared: | September 20, 2003 | | | | Name of the Device: | Device , Electrosurgical, Cutting & Coagulation &<br>Accessories | | | | Proprietary Name:<br>Models: | SHINMED various models of electro-surgical pencils<br>SW12200, SW12202, SW12300 | | | | Predicate Device: | Gyrus PlasmaKinetic Superpulse System<br>(Generator & Accessories) | | | | | 510K No - K031085 | | | {1}------------------------------------------------ ge 2 of (4) Statement of Intended Use: The Shinmed Various Models of Electro-Surgical Pencils. SW12200, SW12202, SW12300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. > The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. Comparison to Predicate Devices: The Shinmed Various Model of Electro-Surgical Pencil, SW12200, SW12202, SW12300, have been carefully compared to legally marketed devices with to intended - use and - technological respect characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use. {2}------------------------------------------------ #### 5. 510(K) SUMMARY Page 3 of 4 SHINMED various models of reusable Electro-Surgical Percils, Models: SW11100, SW11200, SW11202, SW11300 510K: K033027 | Submitted by: | SHINING WORLD HEALTH CARE CO., LTD. | |------------------------|-----------------------------------------------------------------| | | 6F, No. 8, Lane 7, Wu-Chun Road, Wu-Ku Industrial Park, | | | Taipei, China (Taiwan) | | Contact person: | Dr. Jen, Ke-Min | | | No.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, ROC | | | Tel: 886-3-5208829 Fax: 886-3-5209783 | | | E-mail ceirs.jen@msa.hinet.net | | Date Summary Prepared: | September 26, 2003 | | Name of the Device: | Device, Electrosurgical, Cutting & Coagulation & Accessories | | Proprietary Name: | SHINMED various models of reusable electro-surgical pencils | | Models: | SW11100, SW11200, SW1202, SW11300 | | Predicate Device: | Gyrus PlasmaKinetic Superpulse System (Generator & Accessories) | | | 510K No - K031085 | {3}------------------------------------------------ lage 4 °6 5 Statement of Intended Use: The Shinried Various Model: of reusable Electro-Surgical Pencils, SW11100, SW11200, SW11202, SW11300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. > The cevice is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. - Devices: The Shinmed Various Model of of reusable Comparison to Predicate Electro-Surgical Penci!, SW1100, SW11200, SW11202, SW11300 have been carefully compared to legally marketed devices with respect to intended use and technological churacteristics. In addition, performance testing has been done to validate the performance of the device. The comparisor. and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that resemble a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 2 2004 Dr. Ke-Min Jen Shining World Health Care Co., LTD. No. 58. Fu-Chiun Street Hsin-Chu City, Taiwan, ROC Re: K033027 KUJ3027 Trade/Device Name: SHINMED Various Disposable Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300, SW11100, SW11200, SW11202, SW11300 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 14, 2004 Received: July 22, 2004 Dear Dr. Jen: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to regary comment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, the eccordance with the provisions of the Federal Food, Drug, de nees mat have been rollire approval of a premarket approval application (PMA). and Cosmetic (110. (110.) market the device, subject to the general controls provisions of the Act. The r ou may, mercerere, manies of the Act include requirements for annual registration, listing of general voltarely provisive, 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 to such additional controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, Title 21, Parts 800 to 898. In addition, FDA may be found in the over 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 that I DT has made a actornmanations administered by other Federal agencies. You must or any I oderal statutes and states and the mot limited to: registration and listing (21 Comply with an the Her 811 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, labeling (21 CFR Part 820); and if applicable, the electronic forth in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Dr. Jen, Ke-Min This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to oegin maine of substantial equivalence of your device to a legally premarket nothleation: "The PDF intelling of casion 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 IT you desire specific advice for your act 100 %. Also, please note the regulation entitled, a Colliation of Compullios as (est notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response 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 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 {6}------------------------------------------------ Page 1 of 2 ## 4. INDICATIONS FOR USE STATEMENT Shining World Health Care Co , I td Applicant 510(k) Number : _ TOBEASSIGNED KO33027 DISPOSABLE Device Name SHINMED Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300 Indications for Use : - The Shinned Various Models of Electro-Surgical Fencils, SW12200, SW12202, ● SW12300 used with a 510k-clearance generator are intended for use for ablation, removal, resection and coagniation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. - The device is intended for use by qualified medical personnel trained in the use ● of electrosurgical equipment Prescription Use Per 21 CFR 801.109 ೧೯ Over-The-Counter (Optional Format 1-2 ५६) (PLEASE DO NOT WRITE BELOW THIS - INE CONTINUE QA ANQUITY B PAGE IF MEEDED, Concurrence of CDRH Office of Nevice Evaluation (ODE) Miriam C. Provost Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** ko 33022 {7}------------------------------------------------ Page 2 of 2 # 4. INDICATIONS FOR USE STATEMENT | Applicant : | SHINING World Health Care Co., Ltd. | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number : | K 033027 | | Device Name : | SHINMED electrosurgical pencils, reusable models: (SW11100, SW11200, SW11202, SW11300 ); disposable models: (SW12200, SW12202, SW12300) | ## Indications for Use : - The SHINMED Various Models of Electro-Surgical Pencils used with a ● The DITANEE generator are intended for use for ablation, removal, Trok-citcal and coagulation of soft tissue and where associated hemostasis is resocion and the endoscopic and laparoscopic surgical procedures. - The device is intended for use by qualified medical personnel trained in the ● use of electrosurgical equipment. | Prescription Use | √ | AND/OR | Over-The-Counter Use | | |-----------------------------|---|--------|------------------------|--| | (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Miriam C. Provost Division Sign-Off of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 510(k) Number K 633027