← Product Code [OTJ](/productcode/OTJ) · K112196 # OCTOTMPORT (K112196) _Dalim Surgnet Corporation · OTJ · Sep 14, 2011 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K112196 ## Device Facts - **Applicant:** Dalim Surgnet Corporation - **Product Code:** [OTJ](/productcode/OTJ.md) - **Decision Date:** Sep 14, 2011 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. ## Device Story OCTO™ Port is a sterile, disposable laparoscopic instrument port used in minimally invasive abdominal surgery. It functions by retracting a small abdominal incision, allowing multiple laparoscopic instruments and cameras to pass into the abdomen. The device consists of a wound retractor and a port cap system. Modifications from the predicate include an added gas valve for pneumoperitoneum maintenance, a 360-degree rotatable port cap, adjustable port heights/arrangements for instrument spacing, and improved sealing for instrument insertion. The device is operated by surgeons in an OR setting. It facilitates surgery by providing a stable, sealed access point that maintains pneumoperitoneum while allowing instrument maneuverability. The patient benefits from the minimally invasive nature of the procedure enabled by the port. ## Clinical Evidence No clinical data. Bench testing only, including appearance, dimension, pressure leak, tensile strength, pressure injection, instrument insertion/removal, fixation, and pneumoperitoneum maintenance tests. ## Technological Characteristics Materials: Silicon Rubber (wound retractor, remover, sealing, gas pipe), Acrylonitrile Butadiene Styrene (ABS) copolymer (frames, port cap, port), Polycarbonate (gas valve). Form factor: Disposable laparoscopic port with wound retractor. Features: 360-degree rotatable port cap, gas valve for insufflation, universal sealing, adjustable port heights/arrangement. Sterilization: Sterile. ## 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 - OCTO™ ([K100045](/device/K100045.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}------------------------------------------------ K112196 Page 1 of 3 # 510(k) Summary SEP 1 4 2011 Submitter: Dalim SurgNET Co. Du Pyo Hong C-308, High Tech Venture, 647-26 Deungchon-dong, Gangseo-gu, Seoul 157-030, Korea Phone: 82-2-3663-6669 Fax: 82-2-2668-6669 # Official Correspondent: Kodent Inc. April Lee 325 N Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116 ### Device Information Trade Name: OCTO™ Port Common Name: Laparoscopic Accessory Classification Name: Endoscope and accessories Product Code: OTJ Regulation Number: 21 CFR 876.1500 Date of Submission: 7/25/2011 #### Indications for Use The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. ### Device Description & Technological Characteristics The purpose of the device modification is to pursue the variety of products for surgeon's preference. Since the submission of the traditional 510(k), K100045, a number of additional nonsignificant modifications were made to the parent OCTO™ as follow: - The color of the device is changed from light blue to upgrade a brand image. . - The thickness of bottom ring of wound retractor is changed to make easy insertion into incision. - The thickness of silicon around the top ring of wound retractor is changed to make easy retraction. ● - The height of wound retractor has been lengthened to be used in obese patients. ● {1}------------------------------------------------ KII2196 Page 2 of 3 - The gas valve was added to OT501S2, whereas the predicate device, OT501S, did not have gas ● valve - The port cap is made to be rotated in 360 degrees due to the preference of users. ● - The location of gas valve is changed to give more spaces for instruments during the surgery. . - The gas valve lever is loosened to make easy to control. . - The connection notches are attached on the port cap to make easy attachment and detachment of . the port cap from wound retractor. - The outer part of retractor is modified to be easily connected from the port cap by snapping. . - A silicone protector is added due to the preference of users. . - The arrangement and size of ports are changed to give wider range of ports. . - The heights of the ports are changed to give more spaces between instruments ● - 12mm universal sealing is modified to make easy to insert clippers and other instruments. . The modified system has the same intended use and fundamental scientific technology as the previously-cleared system, OCTO™ The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen. #### Materials: Wound retractor, remover, sealing, gas pipe were made of Silicon Rubber compound. Upper Frame, lower frame, port cap and the port were made of Acrylonitrile, Butadience, and Styrene copolymer. Gas valve was made of polycarbonate. # Performance testing (Bench): The testing scope for Bench Test was selected to include appearance inspection, dimension test, pressure leak test, tensile strength test, pressure injection test, instrument insertion/removal test, insertion test, fixation test, leak resistance, cannula insertion and removal evaluation, device compatibility, one handed use, retractor removal test and insufflations tube fixation forces maintain pneumoperitomeum. # Performance testing (Animal): Since the mechanism of the device, the material used on the instruction of using the device are identical and consistent with the previously submitted models, no additional animal testing was performed. {2}------------------------------------------------ K112196 Page 3.83 # Biocompatibility Testing: Since the mechanism of the device, the material used on the instruction of using the device are identical and consistent with the previously submitted models, no additional biocompatibility testing was performed. # Predicate Devices: The subject device is substantially equivalent to the following predicate devices: The name of the device: OCTO™ 510(k) Number: K100045 ### Comparison to Predicate Devices: The comparisons have established that the subject of OCTO™Port is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate device of the type currently marketed in the U.S. #### Conclusion: Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and effective when used as intended. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird in flight or a flowing ribbon. The emblem is positioned in the center of the circular text. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Dalim SurgNET Co. % Kodent, Inc. Ms. April Lee 325 N Puente Street. Unit B Brea, California 92821 . Re: K112196 Trade/Device Name: OCTO Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OTJ Dated: August 25, 2011 Received: August 29, 2011 SEP 1 4 2011 Dear Ms. Lee: 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. 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 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 {4}------------------------------------------------ Page 2 - Ms. April Lee 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.lda.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}------------------------------------------------ KII 2196 # Indication for Use 510(K) Number (if known): 112196 Device Name: OCTO™Port Indication for Use: The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. Prescription Use AND/OR Over-The-Counter _________ (Part 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Neil R.P. Ogden for mkm (Division Sign Off) Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112196 --- **Source:** [https://fda.innolitics.com/device/K112196](https://fda.innolitics.com/device/K112196) **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