THE NEEDLE CATCHER

{0}------------------------------------------------ KOSI281 1/3 SEP - 8 2005 # E.D.MEDICAL LTD. # SECTION 10 13/5/05 510(k) Summary Please note 513g reference number CO40275 DATE OF APPLICATION: E.D.Medical LTD APPLICANTS NAME: ADDRESS: 32 Cranmore Avenue Lisburn Rd Belfast BT 96 JH Brian McNicholl CONTACT PERSON: -353-87 239 2023 TELEPHONE: FAX: -353-1-663 6990 SIGNATURE: MANUFACTURING SITE: UK and Pakistan DEVICE DETAILS Needlecatcher™ TRADE NAME: E.D. Medical Ltd ,32 Cranmore Avenue Lisburn rd, Belfast BT9 6 JH, N Ireland Ph 02890 000 Cranno 10000 007100 arroil brian mcoicholl@gflwgrld.com E.D. Medical Ltd ,32 Crainnore Avenue also aisonicholl@ntlworld.com {1}------------------------------------------------ COMMON NAME: Needlecatcher CLASSIFICATION NAME: FORCEPS, HTD ## 10.1 LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS #### CLAIMED Orthopaedic manual surgical instrument e.g. needleholder 888.4540 Orthopacule management Surgery 878.4800 ## 10.2 Description of the device The Needle Catcher ™ is a stainless steel needle grasping The Needie Catcher Catcher mstrument for use in batanting forceps to allow both combined with the tradie grasping in the same instrument. The tissue notaining and cylinder assembly to grasp Needle Catcher - ases a picchire surgery to reduce the risk and shick the Sucare nod hold the needle safely during knot tyinq. ### 10.3 INTENDED USE OF THE DEVICE 10:5 INTEADED Suture needles during stitching and for transporting suture needles throughout the operating field. ### 10.4 TECHNOLOGICAL CHARACTERISTICS The technological characteristics of the Needle Catcher ™ are rne technological existing needle-grasping instruments such as Similar to those of Chisany the traditional needleholder used in suturing and the dissecting the traditional noone stainless steel surfaces to grasp steel surgical needles whilst allowing the tip of the needle to be shielded from patient and operator during use. The additional Shicided of needle-shielding allows the needle to be temporarily stored in a safe place while the surgeon performs other tasks such as knot tying or tissue dissection. {2}------------------------------------------------ The needle is grasped between a piston which descends as the The needle is grasped between a pister a pister and the inner compression on the forceps arms are relaxes the needle compression on the 10.00p s the needle. Surface of a metal cylinder which receives and ## 10.5 SUBSTANTIAL EQUIVALENCE BASED ON PERFORMANCE DATA Using the instrument on artificial skin and animal tissue with a osing the inistration of artinelal clear. variety of surgeons, nurse operators and medical students its variety of Surgeons, harse open to the safe and that it achieves its indicated that it is safe and easy to use its mulcated that to grasping and needle shielding. #### 10.6 CONCLUSIONS II.6 CONCLUSIONS The Needle Catcher ™ is a surgical needle grasping instrument The Needle Cutcher - 15 a vse in suturing tissue to improve specifically designed for asso in our equivalence is claimed to safety and ergonomics. "Subscannial significan of the tissue forceps and need in suturing {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows a logo with a stylized depiction of three human profiles facing right, represented by curved lines. These profiles are stacked on top of each other, creating a sense of depth. Surrounding the profiles is a circular arrangement of text, which appears to be the name of an organization or department. The logo is presented in black and white, with the profiles and text standing out against the background. SEP - 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Brian McNicholl Managing Director E.D. Medical LTD. 32 Cranmore Avenue Lisburn Road Belfast BT9 6 JH United Kingdom Re: K051281 K651261 Trade/Device Name: The Needlecatcher '" Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: HTD Dated: July 7, 2005 Reccived: August 2, 2005 Dear Mr. McNicholl: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 rotty prematics insubstantially equivalent (for the indications referenced and nave decimined the deviced predicate devices marketed in interstate for use stated in the enclosure for legally manced yourse Amendments, or to commerce prior to May 28, 1976. the enactment of the Foderal Hood. Drug commerce prov to May 26, 1776. the endering and of the provisions of the Federal Food. Drug. devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The You may, mercefore, market me devices belyer to the ments for annual registration, listing of general controls provisions of the Act include requirements for annual registrat general Controls provisions of the rice labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see abore) mk. Existing major regulations affecting your device can may be subject to such additional controls. Existing major and condition may be subject to such additional controls. Title 21, Parts 800 to 898. In addition. FDA may be found in the Code of Federal Regulations. Title 21, Parts 800 to 800 may be found in the Code of Poubla. Togerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that 1 DA s issualite of a readersive complies with other requirements of the Act that FDA has made a deletimination administered by other Federal agencies. You must or any Federal statutes and regulations administered of withing to: registration and listing (21 comply with an the Act 3 requirements 01 : good manufacturing practice requirements as set and CTN Fart 807), ademig (21 CTR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ #### Page 2- Mr. Brian McNicholl This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your as trees as your device to a legally premarket notification. The FDA finding of substantial equivalence of your devi premarket notification. The PDA miding of substantial organities 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 advice for your de nee on our same note the regulation entitled, which in the way obtain contact the Office of Complance at (216) 276-576-16-16 (21CFR Part 807.97). You may obtain "Misbranding by reference to premance notification of the Act from the Division of Small other general information on your responsibilities under the Act from the 1900 638-20 other general information on your responsion in the mumber (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-(demanau) html Manufacturers, International and Consulter Plossible Provincial gov/cdrh/dsma/dsmamain.html Sincerely yours, Barbara Buckner for. Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K051281 Device Name: The Needlecatcher™ Indications for Use: The Needlecatcher is designed for grasping suure needles during in Indications for USC. The Neculeeatener is a line. suturing and holding them during transport throughout the operating theatre. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR ()ver-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) i lauo Buelup Sign-Off for MXM is on Digar Oriz) is on of General, Restorativence of CDRH. Office of Device Evaluation (ODE) .1 Neurological Devices .0(k) Number K051281