FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE

{0}------------------------------------------------ APR 1 5 2005 INNOSPINE, INC. 510(k) Submission ## 510(k) SUMMARY InnoSpine, Inc. Functional Anaesthetic Discography (FAD) System 510(k) Notification K043500 #### GENERAL INFORMATION #### Applicant: InnoSpine, Inc. 1766 Sand Hill Road, Unit 404 Palo Alto, CA 94304 Phone: 650-996-2110 FAX: 650-249-0218 #### Contact Person: Laraine Pangelina Regulatory Consultant Experien Group, LLC 155 Moffett Park Drive, Suite A-101 Sunnyvale, CA 94089-1330 Phone: 408-400-0856 FAX: 408-400-0865 #### Date Prepared: December 17, 2004 #### DEVICE INFORMATION The Functional Anaesthetic Discography (FAD) System consists of the FAD Catheter Kit and the FAD Introducer Needle. #### Classification: Class II, Anesthesia conduction catheter, 21 CFR §868.5120 Class II, Anesthesia conduction needle, 21 CFR §868.5150 #### Trade Name: Functional Anaesthetic Discography (FAD) System: - FAD Catheter Kit . - FAD Introducer Needle . CONFIDENTIAL {1}------------------------------------------------ ## Generic/Common Name: Anesthesia conduction catheter Anesthesia conduction needle #### PREDICATE DEVICES #### FAD Catheter Kit: - Spinal Specialties Discography Kit, K960082, cleared 3/21/96 . - Epimed Versa-Kath Epidural Catheter, K023140, cleared 8/15/03 . - Braun Perifix Catheter, K042488, cleared 9/30/04 . ## FAD Introducer Needle: - Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 . - Epimed Quincke Spinal Needle, K022029, cleared 7/30/02 . - Pajunk Touhy Needles, K040965, cleared 9/7/04 . #### INTENDED USE The Functional Anaesthetic Discography (FAD) System is intended for use in delivering The I unchonal I rindothers Broosean inistration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The FAD Introducer Needle is intended for and of same to access the intradiscal space for the purpose of facilitating use to access the area agatheter and Guidewire into the intradiscal space. #### PRODUCT DESCRIPTION The Functional Anaesthetic Discography (FAD) System consists of the FAD Catheter Kit The FAD Introducer Needle. The FAD Catheter Kit includes one FAD Catheter, one alle the I AD Introducer Needle, and other purchased accessories, including one Ouldewine, one 1 AD introducer Nocarener, two 1 cc syringes and two Touhy-Borst adapters. The FAD Catheter is a micro-catheter with a flexible polymer shaft. There is a polymer TIC I AD Catheter 15 a miero cannote Catheter, which is expanded once the catheter is in allow near the unsul up of the ring over catheter placement during the delivery of fluids place for the purpose of manualing pror to removal of the catheter. Two mo the mitradibed spares in polymer shaft of the catheter, one for the purpose of expanding the anchor, the other for the purpose of tracking over the guidewire and injecting the desired fluid. There are two radiopaque markers, one proximal to the anchor and one the desired from. "There as w for radiographic positioning of the anchor. There is also a disur to the ancher ver which the catheter is tracked to the desired location. The FAD Introducer Needle is provided in the FAD Catheter Kit and will also be sold The TAD Introducer Neducer Needle is stainless steel and has a stainless steel stylet. The #### CONFIDENTIAL {2}------------------------------------------------ FAD Introducer Needle provides access to the intradiscal space. The Guidewire and Catheter are delivered through the FAD Introducer Needle. ## SUBSTANTIAL EQUIVALENCE: The Functional Anaesthetic Discography (FAD) System consists of the FAD Catheter Kit and the FAD Introducer Needle. ## FAD Catheter Kit: FAD Catheter Kit has substantially equivalent indications for use, and technological characteristics as the predicate devices which include: - Spinal Specialties Discography Kit, K960082, cleared 3/21/96 . - Spimal Specialites Discognify, 1023140, cleared 8/15/03 . - Braun Perifix Catheter, K042488, cleared 9/30/04 . The indications for use for the predicate devices are substantially equivalent to the proposed I he indications for use for the predicals derress in the technological characteristics indications for use for the FAD System. Any differences in the technological of AD indications for use for the PAD Dystem vissues of safety or efficacy. Thus, the FAD Catheter Kit is substantially equivalent to the predicate devices. ## FAD Introducer Needle: F AD Introducer Needle has substantially equivalent indications for use, and The I AD Introducer Prostics as the predicate devices which include: - Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 . - Draum Formix Spinal Needle, K022029, cleared 7/30/02 . - Pajunk Touhy Needles, K040965, cleared 9/7/04 . The indications for use for the predicate devices are substantially equivalent to the proposed The indications for use for the predicate do recordinate. Any differences in the technological indications for use for the PAD introducer receinty new issues of safety or efficacy. Thus, characteristics between the devices do not rail ranswitzent to the predicate devices. ## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION Any differences in technological characteristics between the FAD System and the predicate Any differences in technological characteristics occircuit. The safety of the FAD System was devices do not false ally new issues of sales, or sales, or docompatibility testing, evaluated through design vermeation the FAD Catheter Kit and the FAD introducer I he collective results have demonstation that the respective predicate devices with regard to safety. ### SUMMARY The FAD Catheter Kit and the FAD Introducer Needle are substantially equivalent to the predicate devices. ### CONFIDENTIAL {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 5 2005 InnoSpine, Incorporated C/O Ms. Laraine Pangelina Regulatory Consultant Experien Group, LLC 11240 Magdalena Road Los Altos Hills, California 94024 Re: K043500 Trade/Device Name: Functional Anaesthetic Discography (FAD) Catheter System Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: March 21, 2004 Received: March 24, 2005 Dear Ms. Pangelina: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Ms. Pangelina 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. or must comply with all the Act's requirements, including, 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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small 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/industry/support/index.html. Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K043500 Device Name: Functional Anaesthetic Discography (FAD) Catheter System Indications for Use: The Functional Anaesthetic Discography (FAD) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopague contrast, local anaesthetics, and/or saline solution to the intradiscal space. The FAD Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the FAD Catheter and Guidewire into the intradiscal space. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Clu Cs y General Hospital, fection Com...onic Devices Number K043500 Page 1 of 1 (Posted November 13, 2003)