REPROCESSED HOT BIOPSY FORCEPS

{0}------------------------------------------------ # JUL 2 0 2005 Image /page/0/Picture/1 description: The image shows the text "K050136" at the top. Below that, the text "PAGE 1 OF 2" is visible. The text appears to be handwritten in black ink on a white background. The image seems to be a page number or identification marker. #### SUMMARY AND CERTIFICATION SECTION 2. # 2.A. 510(K) SUMMARY . | Submitter: | SterilMed, Inc. | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dr. Bruce R. Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: 763-488-3350 | | Date Prepared: | January 19, 2005 | | Trade Name: | Reprocessed Hot Biopsy Forceps | | Classification Name:<br>and Number: | Electric Biopsy Forceps<br>Class II, 21 CFR 876.4300 | | Product Code: | NLU | | Predicate Device(s): | The reprocessed hot biopsy forceps are substantially<br>equivalent to: "Thermal Option" Hot Biopsy Forceps<br>(K932790), manufactured by Ballard (formerly Cox); "The<br>Shark" Hot Biopsy Forceps manufactured by Wilson-Cook<br>(K923470); "Radial Jaw" Hot Biopsy Forceps (K860366),<br>manufactured by Microvasive; and "Precisor" Hot Biopsy<br>Forceps (K905088), manufactured by Bard (formerly<br>ESCO). | | Device Description: | The device consists of a proximal handle containing an<br>electrosurgical plug which is connected, via a coil, spring<br>or rod mechanism, to the biopsy cup or alligator forceps at<br>the distal tip. The biopsy forceps range from 160 to 240<br>cm in length and 2.2-2.5 mm in diameter. The jaws range<br>from 2.2 to 2.5 mm in diameter. The cup forceps may or<br>may not have serrated edges, a fenestration, needle, or<br>distal biting tooth. | | | The forceps are covered with a sheath of electrical<br>insulation. The electrosurgical plug on the handle used for<br>connection to the appropriate electrosurgical unit. This<br>submission does not include the electrosurgical box that the<br>forceps connect to or its associated connecting cable. | | Intended Use: | The reprocessed hot biopsy forceps are intended to be used<br>for endoscopic tissue sample acquisition, controlled<br>coagulation/cautery, and sessile polyp removal in the<br>gastrointestinal tract. | | Functional and<br>Safety Testing: | Representative samples of reprocessed hot biopsy forceps<br>underwent bench testing to demonstrate appropriate<br>functional characteristics. Process validation testing was<br>done to validate the cleaning and sterilization procedures as<br>well as the device's packaging. In addition, the<br>manufacturing process includes visual and functional<br>testing of all products produced. | | Conclusion: | The hot biopsy forceps reprocessed by SterilMed are<br>substantially equivalent to the following specific predicate<br>devices: "Thermal Option" Hot Biopsy Forceps (K932790),<br>manufactured by Ballard (formerly Cox); "The Shark" Hot<br>Biopsy Forceps manufactured by Wilson-Cook (K923470);<br>"Radial Jaw" Hot Biopsy Forceps (K860366),<br>manufactured by Microvasive; and "Precisor" Hot Biopsy<br>Forceps (K905088), manufactured by Bard (formerly<br>ESCO). This conclusion is based upon the devices'<br>similarities in functional design, materials, indications for<br>use and methods of construction. | {1}------------------------------------------------ ・ {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is depicted with three curved lines forming its body and wings. The logo also includes text arranged in a circular pattern around the bird, although the specific text is not clear due to the image quality. The overall design is simple and abstract. JUL 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Bruce R. Lester, Ph.D. Vice President of R&D SterilMed, Inc. 11400 73rd Avenue North MAPLE GROVE MN 55369 Re: K050136 Trade/Device Name: SterilMed Reprocessed Hot Biopsy Forceps (see enclosure) Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: April 27, 2005 Received: April 28, 2005 Dear Dr. Lester: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have route determined the device is substantially equivalent (for the indications for use stated in above and have as a legally marketed predicate devices marketed in interstate commerce prior to the cholors, the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1710, and classified in accordans of the Federal Food, Drug, and Cosmetic Act (Act) that tecassinod in accordatios approval application (PMA). You may, therefore, market the do not require approvations of the Act. The general controls provisions of the Act. device, subjoc to 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 If your device is older to such additional controls. Existing major regulations affecting your Approval), a the you be boor 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 I caral statues and rogalding, 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) (2) CFR Part 807); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to ogin manenes of your device of your device to a legally premarked nothleation: "The PDF mailig sification 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 If you desire specific auvice tor your acrees on the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, " have the on your responsibilities under the Act from the 807.97). Tou Inay Outain other general 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/industry/support/index.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 {4}------------------------------------------------ ## Attachment - Reprocessed Hot Biopsy Forceps (K050136) | Bard | |-------------| | 000852 | | 000853 | | 000854 | | 000856 | | Ballard | | 60101 | | 60102 | | 60103 | | 60104 | | 60107 | | 60108 | | 60109 | | 60110 | | 60113 | | 60114 | | 60115 | | 60116 | | 60119 | | 60120 | | 60121 | | 60122 | | Microvasive | 1 250 ### Wilson-Cook HS-2.5-230 HDS-2.5-230 '문관 1 : . {5}------------------------------------------------ # Indications for Use | 510(k) Number (if known): | K050136 | |---------------------------|--------------------------------| | Device Name: | Reprocessed Hot Biopsy Forceps | | Indications For Use: | | The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Darrey C. hagdon (Division Sign Off) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 0501-510(k) Number _