ENSPIRE DEBRIDER SYSTEM

{0}------------------------------------------------ Traditional 510(k) enSpire™ Discectomy System # 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## Name, Address, Phone and Fax Number of Applicant A. Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 623-1931 (510) 490-1753 Fax: ## B. Contact Person Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net ## C. Date Prepared April 7, 2011 #### D. Device Name | Trade Name: | enSpire™ Discectomy System | |----------------------|----------------------------------------------------------------| | Common Name: | Arthroscope & Accessory | | Classification Name: | Arthroscope & Accessories (21 CFR §888.1100, Product Code HRX) | ### E. Predicate Devices The enSpire™ Discectomy System is substantially equivalent to the Spine View enSpire™ Debrider System cleared under K090278 on April 15, 2009. · · () {1}------------------------------------------------ Kllo992 Spine View, Inc. ## F. Device Description The enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device. #### G. Intended Use The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. #### H. Technological Comparison The enSpire™ Discectomy System has similar features as compared to the predicate devices in the table below. | Feature | Spine View, Inc.<br>Spine View ENSPIRE™ Debrider<br>System<br>K090278 | Spine View, Inc.<br>enSpire™ Discectomy System<br>K110992 | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Spine View. ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | | Product Code | HRX<br>Arthroscope, 21CFR888.1100, Class II, (Debrider)<br>NBH, Class I exempt (Introducer Cannula with Stylet) | HRX<br>Arthroscope, 21CFR888.1100, Class II, (Debrider)<br>NBH, Class I exempt (Introducer Cannula with Stylet) | | Principal Operator | Physician | Physician | | Use Location | Operating Room or Medical Suite | Operating Room or Medical Suite | | Operating Principal | Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories | Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories | | Functions of Included<br>Devices | Dilatation<br>Access<br>Excision<br>Aspiration | Dilatation<br>Access<br>Excision<br>Aspiration | | Mechanics of Action | Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories | Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories | | Target Anatomy | Intervertebral procedure | Intervertebral procedure | | Design Features | Auger housed in a tube, with retractable cutting assembly (spiral | Auger housed in a tube, with retractable rotating cutting assembly (spiral wire or | | Feature | Spine View, Inc.<br>Spine View ENSPIRE™ Debrider<br>System<br>K090278 | Spine View, Inc.<br>enSpire™ Discectomy System<br>K110992 | | | wire) on the distal end. It is driven by<br>a battery-powered motor that is<br>housed in a plastic handle at the<br>proximal end of the device.<br>Cut debris can pass up the tube and<br>into the collection chamber located at<br>the end of the auger. It is inserted<br>into the surgical site either directly,<br>via an introducer cannula or<br>Arthroscope.<br>Working Shaft straight. | curette style cutter) on the distal end. It<br>is driven by a battery-powered motor that<br>is housed in a plastic handle at the<br>proximal end of the device.<br>Cut debris can pass up the tube and into<br>the collection chamber located at the<br>end of the auger. It is inserted into the<br>surgical site either directly, via an<br>introducer cannula or Arthroscope.<br>Working shaft: straight, curved or<br>articulating. | | Tip Materials | Stainless Steel and Solder | PEEK, Aramid Fiber, Polyimide,<br>Stainless Steel, and Tungsten | | Sterile Packaging | The ENSPIRE™ Debrider System is<br>placed onto a polyethylene card and<br>sealed in a Tyvek/Mylar pouch. That<br>pouch is placed into a whiteboard<br>unit carton. | The enSpire™ Discectomy System is<br>placed into a thermo formed tray with a<br>thermoformed insert lid, and sealed with<br>a Tyvek tray lid. The sealed tray is then<br>placed in a labeled chip board shelf<br>carton. | | Sterilization Method | Electron Beam | Gamma | | Biocompatible for<br>Intended Use | Yes | Yes | | Single use | Yes | Yes | | Configuration | Straight | Straight, Curved, Articulating | | Handle Design | Hand-held rotary device, in-line grip | Hand-held rotary device, in-line grip or<br>pistol-grip | | Profile | 0.046" OD working shaft with tip<br>0.27" OD deployed, 0.052" OD<br>unexpanded. | 0.046-0.165" OD working shaft with tip<br>0.28-0.40" OD deployed, 0.058-0.22" OD<br>unexpanded | | Working Length | 8 - 11" working length | 2 - 22" working length | | Energy Type | Mechanical | Mechanical | | Power | Battery, 9V | Battery, 9V or 18V | | Meets Applicable<br>IEC60601-1 testing | Yes | Yes | | User<br>visualization/guidance | Direct visualization, fluoroscopic<br>imaging | Direct visualization, fluoroscopic imaging | . Appendix A, Page 2 of 4 {2}------------------------------------------------ ## Spine View, Inc. ## Traditional 510(k) enSpire™ Discectomy System The technological characteristics and principals of operation of the enSpire™ Discectomy System are substantially equivalent to the named predicate device. l. Summary of Non-Clinical Data > The enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies: {3}------------------------------------------------ # 4110992 ## Spine View, Inc. ## Traditional 510(k) enSpire™ Discectomy System - Tissue Removal ● - Cannula Compatibility . - Enable Switch Durability . - . Deployment & Retraction - Working Shaft Length . - . Device Durability - . Travel Limiter Attachment - . Travel Limiter - Tensile Strength . - Articulation Function . - . Articulation Angle - Visualization . - Peak Temperature during . Operation Tissue Volume/Material Removal No Breach of Annulus or Endplates - · Electromagnetic Compatibility and Electrical Safety - · Packaging Testing - · Shipping Testing - · Sterility Testing - · Shelf Life Testing - · Biocompatibility: - Cytotoxicity o - Sensitization O - Irritation 0 - Systemic Toxicity 0 Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the enSpire™ Discectorny System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the enSpire™ Discectomy System is substantially equivalent to the named predicate. #### J. Summary of Data . . The enSpire™ Discectomy System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the enSpire™ Discectorny System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the enSpire™ Discectomy System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus, indicating the department's name and country. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 2 1 2011 Spine View, Inc. % Mr. Mbithi Muthini Director, Quality and Regulatory 48810 Kato Road, Suite 100E Fremont, California 94538 Re: K110992 Trade/Device Name: enSpire™ Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 20, 2011 Received: September 22, 2011 ## Dear Mr. Muthini: 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 Amendmouts, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 {5}------------------------------------------------ Page 2 - Mr. Mbithi Muthini or any Federal statutes and regulations administered by other Federal agencies. You 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Eriel Keith Cor Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Spine View, Inc. ## Indications for Use Statement 510(k) Number (if known): K110992 K Device Name: enSpire™ Discectomy System Indications for Use: The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. Prescription Use × OR Over-The-Counter Use (per 21 CFR 801.109) PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Neil RP Ogden for MKN Division Sign Off Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110992