← Product Code [GCJ](/productcode/GCJ) · K101671 # SINGLE SITE FLEXIBLE BLADELESS OBTURATOR (K101671) _Teleflexmedical, Inc. · GCJ · Jun 25, 2010 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K101671 ## Device Facts - **Applicant:** Teleflexmedical, Inc. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Jun 25, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. ## Device Story Single-use, 5mm diameter, 304mm length sterile dilating obturator; used with Intuitive Surgical DaVinci SI robot Curved Cannula. Obturator features proximal cap locking onto cannula rim. Used in OR by surgeons during minimally invasive procedures to create access pathway for endoscopic instruments. Device facilitates smooth transition between cannula and obturator tip. Benefits include safe, atraumatic tissue penetration and stable port assembly for robotic surgery. ## Clinical Evidence Bench testing only. Verification testing demonstrated successful insertion and removal from the Curved Cannula without material degradation. ## Technological Characteristics Sterile, single-use, 5mm diameter, 304mm length dilating obturator. Materials are identical to predicate K010007. Mechanical locking mechanism for cannula interface. No energy source. No software. ## 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - ADAPT™ Laparoscopic Port and Accessory ([K010007](/device/K010007.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KC01671 #### Single-Site™ Flexible Bladeless Obturator Special 510(k) Section 8 - Summary of Safety and Effectiveness #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS #### Single-Site™ Flexible Bladeless Obturator JUN 25 2010 ### A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4904 Fax: 919-433-4996 #### B. Contact Person Angela Bouse Sr. Regulatory Affairs Specialist #### C. Date Prepared June 11, 2010 ### D. Device Name Trade Name: Single-Site™ Flexible Bladeless Obturator Common Name: Surgical Trocar Classification Name: Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ) #### E. Device Description The Single-Site™ Flexible Bladeless Obturator is a sterile, single-use 5mm diameter X 304 mm length dilating obturator that is used in conjunction with a 5mm Curved Cannula. The Obturator has a cap at the proximal end that locks onto the Curved Cannula rim. The Curved Cannula is designed by Intuitive Surgical, Inc. (ISI) for use with their DaVinci SI robot model. ## F. Indications for Use The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. CONFIDENTIAL {1}------------------------------------------------ # G. Contraindications Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed. # H. Substantial Equivalence The proposed Single-Site™ Flexible Bladeless Obturator is substantially equivalent to the predicate device: | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |------------------------------------------------|----------------------------------------|------------|--------------| | The ADAPTTM Laparoscopic
Port and Accessory | Teleflex Medical, Inc. /
Taut, Inc. | K010007 | 02/22/2001 | # I. Comparison To Predicate Device The tip design and function of the proposed Single-Site™ Flexible Bladeless Obturator is identical to the predicate device's Obturator component except that the Single-Site™ Flexible Bladeless Obturator has the following changes: - 304mm obturator length; . - The Tip Length is longer, this insures a smooth transition area between the . distal cannula end and the obturator tip. The Tip Length is described as the section of the obturator tip that protrudes from the cannula after the obturator is inserted into the cannula; - The Obturator Cap designed to lock and unlock from the Curved Cannula rim . to support obturator / cannula assembly: - IFU revision for clarity to insure proper use of the Obturator with the Curved . Cannula. # J. Materials All materials that have patient contact have been cleared in predicate device under 510(k) K010007. There are no new patient contact materials used in Single-Site™ Flexible Bladeless Obturator. # K. Performance Data Verification testing was performed to demonstrate that the proposed Single-Site™ Flexible Bladeless Obturator is inserted and removed from the Curved Cannula without any evidence of material degradation. {2}------------------------------------------------ # L. Conclusion The test results demonstrate the proposed Single-Site™ Flexible Bladeless Obturator is compatible with the ISI Curved Cannula. The changes made to the proposed Single-Site™ Flexible Bladeless Obturator do not introduce any new issues of safety and effectiveness. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 # JUN 2 5 2010 Teleflex Medical, Inc. % Ms. Angela Bouse Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709 Re: K101671 K101071 Trade/Device Name: Single-Site™ Flexible Bladeless Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 11, 2010 Received: June 14, 2010 Dear Ms. Bouse: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard the Medical Device Amendments, or to commerce pror to this 2011/2017 11:23 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosment Act (110) market the device, subject to the general controls provisions of the (1 MA). Tou may, morelere, mainer of the Act include requirements for annual registration, Act. The general controls provision of practice, labeling, and prohibitions against misbranding Irsung of devices, good manazavaning possible information related to contract liability alle adultion. Thease now 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 If your device is blassified (bee arone). Existing major regulations affecting your device can be may be subject to additional controller and the 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 i lease oc advisod may be results at your device complies with other requirements of the Act {4}------------------------------------------------ Page 2 - Ms. Angela Bouse 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 yours, Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Page 1 of 1 510(k) Number: K101671_ Device Name: Single-Site™ Flexible Bladeless Obturator Indications for Use: The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR Over-the-counter use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Niel R. Oshrin Sir m.kin (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K101671 : --- **Source:** [https://fda.innolitics.com/device/K101671](https://fda.innolitics.com/device/K101671) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com