← Product Code [NTN](/productcode/NTN) · K102167 # LO-50 LED LIGHT SOURCE (K102167) _Fiberoptics Technology, Inc. · NTN · Aug 17, 2010 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K102167 ## Device Facts - **Applicant:** Fiberoptics Technology, Inc. - **Product Code:** [NTN](/productcode/NTN.md) - **Decision Date:** Aug 17, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** 3rd-Party Reviewed ## Indications for Use The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures. ## Device Story LO-50 LED Light Source provides illumination for surgical sites; utilizes single solid-state LED element; converts electrical energy to visible light via electroluminescence; employs Pulse Width Modulation (PWM) to control LED on/off time for brightness adjustment; includes cooling fan, light port, and manual dimming control. Device used in OR or clinical settings; operated by physicians or surgical staff. Light transmitted via accessory fiber optic light guides to arthroscopes or surgical headlights. Enables indirect visualization of surgical field; facilitates minimally invasive procedures. Bench testing confirms equivalent brightness, thermal characteristics, and safety compared to predicate. ## Clinical Evidence Bench testing only. Evaluated operation, user interface, light quality, and safety. Measured brightness of light emitted via reference light guides and compared illumination quality for arthroscopes and headlights. Compared operating temperatures of light sources, accessible parts, and instruments. Results showed equivalent performance and temperature characteristics to predicate. ## Technological Characteristics Solid-state LED light source; uses Pulse Width Modulation (PWM) for brightness control. Includes cooling fan, light port, sheet metal/plastic housing. Conforms to UL60601-1, CAN/CSA 22.2 No. 601.1, and EN60601-1-2 (EMC). ## 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 - Sunoptics Technologies LLS-050 LED Light Source ([K093792](/device/K093792.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 of Safety and Effectiveness Statement ### Device Name; AUG 1 7 2010 Proprietary Name: Common and Usual Name: Classification Name; LO-50 LED Light Source Light Source, Illuminator Light Source, Fiberoptic, Routine, CFR 21 §876.1500 #### Manufacturer Information: Fiberoptics Technology, Inc. 1 Quassett Road Pomfret, CT 06258 USA ## Establishment Registration Number: 1222275 ### FDA Device Classification | Device Description: | Gastroenterology - Endoscope and Accessories | |---------------------|----------------------------------------------| | Medical Specialty: | General and Plastic Surgery | | Product Code: | FCW | | 510(k) Exempt? | No | | Regulation Number: | 876.1500 | Product Description: The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device. Indications for Use;_The LO-50 Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a headlight for general surgical or examination procedures. Voluntary Safety and Performance Standards; The LO-50 LED Light Source conforms to the following Medical Device Safety Standards: UL60601-1, CAN/CSA 22.2 No. 601.1. The LO-50 Light Source conforms to the Medical Device EMC Standard EN60601-1-2. ### Predicate Device: The LO-50 LED Light Source is substantially equivalent in terms of safety and effectiveness to the currently marketed predicate device: Sunoptics Technologies LLS-050 LED Light Source (K093792). #### Performance and Safety Comparison to Predicate Device: Both light sources were non-clinically tested to determine the safety and efficacy under the indications for use. The units were tested for operation, user interface, light quality and safety during use. User controls and operations were examine and compared, as well as ease of connection of common light guides. The brightness of light emitted by a reference light guide from each unit was measured. Brightness and quality of illumination from a typical fiber optic headlight system and arthroscope was examined and compared. Operating temperatures of the light sources, accessible parts and lighted instruments were measured and compared. Each unit had essentially equivalent performance and temperature characteristics. Fiberoptics Technology, Inc. LO-50 510k Submission Page 6 {1}------------------------------------------------ #### Substantial Equivalence: The technological differences between the LO-50 Light Source and Sunoptics Technologies LLS-050 LED Light Source do not raise new questlons of safety or effectiveness. Both light sources produced equivalent brightness and quality of light, were similar in control and operation, interfaced correctly and effectively to the arthroscope and surgical headlight used to test and verify performance. The LED technology, power supply, user interface and connectivity are nearly identical. Therefore, the LO-50 Light Source is substantially equivalent to the predicate marketed device. Contact: Allan Guillotte the text "Allan Guillotte" is a signature, and the date is 08/17/10 Fiberoptics Technology, Inc. 1 Quassett Road Pomfret, CT 06258 (860) 928-0443 {phone}; (860) 928-7664 (fax); or e-mail aguillotte@fibeoptix.com Fiberoptics Technology, Inc. LO-50 510k Submission {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be part of a document or official letterhead. The ampersand symbol (&) is also present in the text. Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Fiberoptics Technology, Inc. % Regulatory Technology Services, Inc. Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313 AUG 1 7 2010 Re: K102167 Trade/Device Name: LO-50 LED Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN, FCW Dated: July 30, 2010 Received: August 02, 2010 Dear Mr. Job: 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 {3}------------------------------------------------ # Page 2 - Mr. Mark Job 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/ResourcesforYou/Industry/default.htm. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark A. Mckenna Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K102167 # Indications for Use 510(k) Number (if known): Device Name: LO-50 LED Light Source Indications for Use: The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Neil R.E. Ogden formx (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102167 Page 1 of _ --- **Source:** [https://fda.innolitics.com/device/K102167](https://fda.innolitics.com/device/K102167) **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