← Product Code [GCJ](/productcode/GCJ) · K013617 # LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS (K013617) _Olympus Optical Co., Ltd. · GCJ · Jan 30, 2002 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K013617 ## Device Facts - **Applicant:** Olympus Optical Co., Ltd. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Jan 30, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. ## Device Story LTF-240 Pleuravideoscope is a flexible endoscope used for visualization and surgical procedures within thoracic and abdominal cavities. Device connects to Olympus video system centers, light sources, monitors, and documentation equipment. Operates as a flexible alternative to traditional rigid endoscopes for electrosurgical applications. Used by physicians in clinical settings to perform endoscopic diagnosis and surgery. Provides visual feedback to the clinician via a display monitor, facilitating navigation and therapeutic intervention (e.g., biopsy). Benefits include flexible access to body cavities for minimally invasive procedures. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design similarity to the predicate LTF-V and compliance with IEC 60601-1 and IEC 60601-2-18 safety standards. ## Technological Characteristics Flexible endoscope; utilizes Olympus video system center and light source. Complies with IEC 60601-1 and IEC 60601-2-18. No new patient-contacting materials; all materials previously cleared in predicate submissions. ## 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 - OES Laparo-Thoracoscope LTF-V ([K955403](/device/K955403.md)) - Laparoscope, Hand Instruments ([K950103](/device/K950103.md)) - Flexible Trocar Tubes ([K930215](/device/K930215.md)) - Flexible Tip Thoracoscope/Laparoscope ([K915857](/device/K915857.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}------------------------------------------------ ## 510(k) SUMMARY JAN 3 0 2002 K013617 1/2 ## LTF-240 Pleuravideoscope, its accessories and ancillary equipment This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92. ### A. Submitter's Name, Address, Phone and Fax Number ### 1. Manufacturer of the subject device Name & Address of Manufacturer; Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division 2 Name of Contact Person Name : Address, Phone and Fax Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioii-shi. Tokyo 192-8507 Japan TEL 81-426-42-5177 FAX 81-426-46-5613 Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416 B. Device Name, Common Name - 1. Device Name : - 2. Common/Usual Name : - 3. Classification Name : LTF-240 Pleuravideoscope, its accessories and ancillary equipment Video Scope for Pleuravideoscope 21CFR 884.1720 21CFR 876.1500 {1}------------------------------------------------ ### C. Predicate Devices: | Model | Device Description &
410(k)#/Date of Cleared | Manufacturer | Class | |------------------------------------------|-------------------------------------------------|-----------------------|-------| | OES Laparo-Thoracoscope
LTF-V | #K955403 | Olympus Optical Co., | II | | Laparoscope,
Hand Instruments | #K950103 | Olympus America, Inc. | II | | Flexible Trocar Tubes | #K930215 | Olympus Optical Co., | II | | Flexible Tip
Thoracoscope/Laparoscope | #K915857 | Olympus Optical Co., | II | #### Summary Description of the Device D. #### 1. Summary This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source. #### 2. Design "XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18. #### 3. Materials There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions. #### Intended Use of the device E. This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment of endoscopic diagnosis with the nasal and nasopharyngeal lumen. #### F. Technological Characteristics This endoscope does not have special technological characteristics, when compared to the predicate device. #### G. Reason for not requiring clinical data The subject device, LTF-240, is basically identical to the LTF-V laparoscopic thoracoscope, which is a flexible endoscope indicated for use in the thoracic and abdominal cavities, with the exception being that the LTF-V is not indicated for electrosurgery applications. Historically, electrosurgery within the thoracic and abdominal cavities has been performed using a rigid endoscope. The use of the subject device, which is a flexible endoscope, should present no differences in safety or efficacy when compared to the predicate devices for electrosurgical applications. {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 stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 0 2002 Olympus Optical Company, Ltd. c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747 Re: K013617 Trade/Device Name: LTF-240 Pleuravideoscope, accessories and ancillary equipment Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 1, 2001 Received: November 5, 2001 Dear Ms. Storms-Tyler: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 2015, 10:10 accordance with the provisions of the Federal Food, Drug, de rices that have occh require approval of a premarket approval application (PMA). and Cosmetion (110. (110.) that the device, subject to the general controls provisions of the Act. The r ou may, dierelove, manier the act include requirements for annual registration, listing of general controls provisions of vactice, 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 If your device is etablined too as controls. Existing major regulations affecting your device can may oe subject to back additions, 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 r lease be deviced that I Dr mination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fart 6077, laboring (21 CFR Part 820); and if applicable, the electronic for the qualis) by becam (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 -- Ms. Laura Storms-Tyler This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premits that in the Pro Pro maining of casion 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 and If you desire specific advice for your witto diagnostic devices), please contact the Office of additionally 21 CHC Fur 80711 Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1037. Transe Compliance at (301) 594-4639. Also, please note the your dovice, prease occident by reference to premarket notification" (21CFR Part 807.97). Tegulation chitted, "Nisoranaing of esponsibilities under the Act may be obtained from the Oincl general information on your responsional 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/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Cor Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ **OLYMPUS!** # Indication for Use Statement 510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ Not assigned y LTF-240 Pleuravideoscope, its accessories and Device Name: ancillary equipment. ### Indications for Use: This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. Miriam C. Provost Division of General, Restorative and Neurological Devices 510(k) Number K013617 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) --- Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (Prescription 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K013617](https://fda-staging.innolitics.com/device/K013617) **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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