LIGHT SABER INTRODUCER NEEDLE

{0}------------------------------------------------ K013040 ## EXHIBIT A - 510(K) SUMMARY MINRAD, INC. LIGHT SABER™ INTRODUCER NEEDLE DEC 0 7 2001 Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared MINRAD, INC. 847 Main Street Buffalo, NY 14203 Phone: (716)-855-1068 Facsimile: (716)-855-1071 Contact Person: John Riggi Director, Regulatory Affairs August 29, 2001 Date Prepared: #### Name of Device and Name/Address of Sponsor Light Saber™ Introducer Needle MINRAD, INC. 847 Main Street Buffalo, NY 14203 #### Common or Usual Name Surgical Guide Needle/General and Plastic Surgery, Cannula #### Classification Name Surgical Guide Needle/General and Plastic Surgery, Cannula #### Predicate Devices - 1. Introducer Needle Accessory, Oratec Interventions, Inc. - 2. Light SaberTM Aspiration Needle, MINRAD, Inc. {1}------------------------------------------------ # EXHIBIT A - 510(K) SUMMARY MINRAD, INC. LIGHT SABER™ INTRODUCER NEEDLE (cont.) #### Intended Use The Light Saber™ Introducer Needle is intended to be a single use disposable The Light Daber introducer needler.amidia micentisa intenducer Needle is generally non-vascular procedures: - The Esgle starter. indicated to gain percutaneous access to the body for surgical procedures and mulcated to gain percultures with the DRTS to improve the accuracy of needle placement. ### Technological Characteristics Iological Onaraover Ibereo Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals. #### Substantial Equivalence The MINRAD, INC. Light Saber™ Introducer Needle is substantially The MINI-a-13, 11. 01 he currently marketed devices, which are referenced equivalent to the other odifferences in general indications for use, size of the abover and needle tip configurations, the MINRAD, INC. Light Saber™ Introducer Needle is identical to a combination of its predicate devices. These minor differences raise no new issues of safety or effectiveness. Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Riggi Director, Regulatory Affairs MINRAD, Inc. 847 Main Street Buffalo, New York 14203 DEC 0 7 2001 Re: K013040 Trade/Device Name: Light Saber™ Introducer Needle Regulation Number: 880.5860, 878.4800 Regulation Name: Piston syringe Manual surgical instrument for general use Regulatory Class: II Product Code: FMF, MDM Dated: September 7, 2001 Received: September 10, 2001 Dear Mr. Riggi: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as sured in the encreated of the enactment date of the Medical Device Amendments, or to coniments provision to May 20, 1976, the occordance with the provisions of the Federal Food, DINEA devices that have been recuired in assee approval of a premarket approval application (PMA). alla Cosmetic 710-11-184, that 20 hot sequence to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 IT your device is classified (500 a00 roy ins. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations FR may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may ou found in the Our cements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1 Dr. 3 issualled of a complies with other requirements of the Act mall I DA has made a determinations administered by other Federal agencies. You must of any i cacal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Hot 601 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 -- Mr. John Riggi This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter with and my your e FDA finding of substantial equivalence of your device to a legally prematics noticated. " The station 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 specific arris 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 8659. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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, R. Mark A. Millison 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}------------------------------------------------ # SECTION 5 - INDICATIONS FOR USE Indications for Use Form KO13040 510(k) Number (if known):_ Device Name: Light Saber™ Introducer Needle Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures. Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement. ### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number. K013040 Prescription Use _V (Per 21 C.F.R. 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)