← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K072811 # MARIONETTE SA, MODEL 001 001 & 001 002 (K072811) _Kinetic Surgical, LLC · GCJ · Apr 21, 2008 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K072811 ## Device Facts - **Applicant:** Kinetic Surgical, LLC - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Apr 21, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. ## Device Story Marionette™ SA is a manually operated, articulating mechanical surgical instrument; used for grasping, dissection, and tissue cutting during laparoscopic procedures. Device enables one-handed control (left or right) for positioning/repositioning of surgical tips. Tips are interchangeable (disposable/reusable). Device is sold non-sterile for hospital-based cleaning and sterilization; some accessories are single-use sterile components. Operated by surgeons in clinical/OR settings to facilitate tissue manipulation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manually operated, articulating mechanical surgical device. Materials: stainless steel, anodized aluminum, Delrin. Provides one-handed control for instrument positioning. Interchangeable tips. Sold non-sterile; requires on-site cleaning and sterilization. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - Endolink True Movement system ([K043541](/device/K043541.md)) - Microline Incorporated Re-New Laparoscopic Instruments ([K962119](/device/K962119.md)) - Cambridge Laparo-Angle ([K061425](/device/K061425.md)) ## Related Devices - [K091869](/device/K091869.md) — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS · Covidien Lp, Formerly Registered AS United States · Sep 1, 2009 - [K151036](/device/K151036.md) — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments · Carefusion 2200, Inc. · Feb 1, 2016 - [K970826](/device/K970826.md) — SELECTA-TIP LAPAROSCOPIC SCISSORS · Microline Pentax, Inc. · Mar 28, 1997 - [K970949](/device/K970949.md) — SMITH & NEPHEW MIS INSTRUMENTS · Smith & Nephew Endoscopy, Inc. · Apr 23, 1997 - [K962119](/device/K962119.md) — RE-NEW LAPAROSCOPIC INSTRUMENTS · Microline Pentax, Inc. · Aug 9, 1996 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for KineticSurgical. The logo consists of a stylized letter "K" inside of a circle, with the name "KineticSurgical" written below it. The font is sans-serif and the color is black. K072811 - P. 1 of 7 APR 2 1 2008 ## Marionette™ SA (Surgical Assistant) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All information included in this document is accurate and complete to the best of KSLLC's knowledge. | Applicant: | Kinetic Surgical LLC<br>6215 Ferris Square, Ste. 100<br>San Diego, CA 92121 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jim Caputo<br>President | | Date of Summary: | April 15, 2008 | | Device Name: | Marionette™ SA | | Common Name: | Grasper, Scissors, & Dissector | | Regulatory Class: | Class II | | Predicate Device: | Endolink True Movement system<br>(K043541)<br>Microline Incorporated Re-New Laparoscopic Instruments<br>(K962119)<br>Cambridge Laparo-Angle<br>(K061425) | | Intended Use: | The Marionette™ SA is intended for use by surgeons for<br>grasping, dissection, and tissue cutting during laparoscopic<br>surgical procedures. | | Device Description: | The Marionette™ SA is a manually operated, articulating<br>mechanical surgical device. It is primarily composed of<br>stainless steel, anodized aluminum and Delrin. The<br>instrument provides for the one handed control (left or right<br>hand) of the positioning/repositioning of an instrument that | {1}------------------------------------------------ f072811 p. 2c 2 includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components. ## Substantial Equivalence: The Marionette™ SA is substantially equivalent in application and function to the Endolink True Movement System, Cambridge Laparo-Angle and the Microline Re-New laparoscopic instrument. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or bird in flight, composed of several curved lines. The design is black and the background is white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Kinetic Surgical, LLC % Mr. Jim Caputo 6215 Ferris Square, Suite 100 APR 2 1 2008 Re: K072811 San Diego, California 92121 President Trade/Device Name: Marionette™ SA (Surgical Assistant) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 7, 2008 Received: April 9, 2008 Dear Mr. Caputo: 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. 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 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. {3}------------------------------------------------ Page 2 - Mr. Jim Caputo 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Mullan Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Ko72811 - p. (c+1 Image /page/4/Picture/1 description: The image shows the logo for KineticSurgical. The logo consists of a stylized letter "K" inside of a circle. The text "KineticSurgical" is written in a sans-serif font below the logo. ## Indications For Use APPENDIX D 510(k) number: K072811 Device Name: Marionette™ SA (Surgical Assistant) The Marionette™ SA is intended for use by surgeons for grasping, dissection, tissue cutting during laparoscopic surgical procedures. Prescription Use (Per 21 CFR 801 Subpart D) OR Over-The-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, O exice Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K072811 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K072811](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K072811) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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