LumiRex Bronchoscope

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 30, 2025 Contra Healthcare Solutions, LLC John O'Conner President 105 Lincoln Avenue Butler, Pennsylvania 16001 Re: K243541 Trade/Device Name: LumiRex Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: March 31, 2025 Received: March 31, 2025 Dear John O'Conner: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243541 - John O'Conner Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K243541 - John O'Conner Page 3 Sincerely, Joyce C. Lin -S for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3} LumiRex Bronchoscope Page 12 of 90 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K243541 | ? | | Please provide the device trade name(s). | | ? | | LumiRex Bronchoscope | | | | Please provide your Indications for Use below. | | ? | | The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary 1. Submitter Contra Healthcare Solutions, LLC 105 Lincoln Avenue Butler PA 16001 United States 724-285-6324 Applicant Contact: Mr. John O'Conner jconnor@alpinsurgical.com 2. Device Name Trade Name: LumiRex Bronchoscope Common Name: Bronchoscope (flexible or rigid) and accessories Classification Name: Bronchoscope (Flexible or Rigid) Regulation Number: 874.4680 Product Code: EOQ 3. Predicate Device Trade Name: Vathin Video Bronchoscope System 510(K) Number: K191828 Product Code: EOQ 4. Device Description Summary The LumiRex Single-Use Bronchoscope is a flexible video-based medical device designed for insertion through the mouth or nose into the trachea and bronchial tubes. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the airways. The bronchoscope also features a working channel that allows for the passage of various instruments, such as biopsy forceps, brushes, and suction devices, facilitating endoscopic procedures. The device is available in different diameters to accommodate a range of patient anatomies and clinical needs. The Bronchoscope can be used wired or wireless through a Wired Scope Adapter or Wireless Scope Adapter. The adapters transmit images from the bronchoscope to the Video Processor Unit where the user can view the image from the bronchoscope, control the LED, and save and export images from the bronchoscope onto USB removable media. 5. Intended Use/ Indications for Use The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for {5} endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment. ## 6. Indications for Use Comparison The subject device LumiRex Bronchoscope has the same intended use as the predicate device Vathin Video Bronchoscope System (K191828). ## 7. Technological Comparison ### Overview of Similarities The subject device and the predicate device have same or similar optical capabilities and conical lock, mostly similar insertion tube characteristics, and some same or similar image characteristics. These similarities do not raise any questions in regard to the safety or performance of the subject device. ### Overview of Differences The subject device allows the user to operate the device wirelessly and wired through respective adapters while the predicate device only has the option of wired use. The wired adapter of the subject device is operated in the same manner as the predicate device. The wireless adapter of the subject device has a built in battery powering the bronchoscope and allows better maneuverability and convenience during use for healthcare providers. The risks of wireless use has been assessed and found to acceptable. The functionality of the bronchoscope with wireless adapter has been validated. The risks associated with wireless use, including latency performance testing to analyze the latency of the video feed transmission from the medical endoscope device to the medical monitor, have been assessed. The testing demonstrates that latency remains within an acceptance range. Notably, latency performance is comparable between the subject device's wired and wireless modes, although latency data for the predicate device was not tested. The subject device has a smaller insertion tube bend radius, allowing better flexibility and maneuverability within a patient's respiratory tract. This does not affect the user's ability to carry out the intended use of the device or introduce any new risks. The subject device has automated White balance and no image enhancement control, this simplifies the user interface and does not affect the user's ability to carry out the intended use of the device or introduce any new risks. Comparative testing between the subject device and predicate device showed that the subject device has a wider field of view and larger depth of view. {6} The subject device has different video format inputs and output formats. However, these do not affect the user's ability to carry out the intended use of the device or introduce any new risks as the LumiRex Video Processor Unit takes the resultant output format and provides the user a display of bronchoscope video image and data storage in a manner similar to the predicate device. The above differences between the subject and predicate device do not raise any questions to the safety and performance of the predicate device. ## 8. Non-Clinical and/or Clinical Tests Summary & Conclusions Non-clinical validation testing was performed to demonstrate the safety and effectiveness of the device. The following tests were performed: ### Sterilization and Shelf-Life Ethelyne Oxide Sterilization of LumiRex Single-Use Bronchoscope has been evaluated to ISO 11135:2014. Sterile Barrier was evaluated to ISO 11607-2:2019 and ASTM F1980 for accelerated aging methodology. The shelf life of the LumiRex Single-Use Bronchoscope has validated. ### Reprocessing Reprocessing of reusable components of the LumiRex Single-Use Bronchoscope has been evaluated in accordance with: - Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2025 - AAMI TIR12:2020 Designing, testing, and labeling reusable medical devices for reprocessing health care facilities: A guide for medical device manufacturers - AAMI/ANSI/ISO 11737-1:2018 Sterilization of health care products-Microbiological Methods Part 1: Determination of the Population Microorganisms on produce - ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities - ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products – Moist heat – Part 1 Requirements for the development, validation, and routine control of a sterilization process for medical devices - AAMI ST98:2022 Cleaning validation of health care products- Requirements for development and validation of a cleaning process for medical devices ### Biocompatibility The biocompatibility evaluation for the LumiRex device was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process" issued September 4, 2020, and International Standard 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," FDA recognition number 258 for: - Cytotoxicity (10993-5:2009) - Sensitization (10993-10:2021) - Systemic Toxicity (10993-11:2017) {7} - Pyrogenicity (10993-11:2017) - Irritation (10993-23:2021) ## Software Software verification and validation testing has been conducted in compliance with IEC 62304 Edition 1.1 2015-06 (which is the principal normative standard applied), ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012 and the FDA guidance documents “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” (11-Jan-2002) and “FDA Guidance for the Content of Premarket Submissions for Device Software Functions” (14-June-2023). ## Cybersecurity The cybersecurity of LumiRex Bronchoscope system was evaluated in conformance to “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” issued September 2023. ## Electrical Safety and Electromagnetic Compatibility The LumiRex Single-Use Bronchoscope, Wired Scope Adapter, Wireless Scope Adapter, Wireless Scope Adapter Charging Cradle, and LumiRex Video Processor have undergone the following Electrical Safety and Electromagnetic Compatibility testing, complying with IEC 60601-1:2005/IEC 60601-1-2:2014+A1:2020/AMD2:2020, IEC 60601-1-2:2014+A1:2020, and IEC 60601-2-18 (3rd edition). ## Wireless The latency of the LumiRex Bronchsope was tested, referring to "Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff". ## Bench Testing - ISO 80369-7:2021 Small-bore Connectors for Liquids and Gases in Healthcare Applications - ISO 8600-1:2015 Endoscopes – General Requirements - ISO 8600-3:2019 Endoscopes – Determination of field of view and direction of view of endoscopes with optics - ISO 8600-4:2014 Endoscopes – Determination of maximum width of insertion portion - IEC 62471:2006 Photobiological Safety - Camera Image Quality - Spatial Resolution MTF (ISO 12233) - Signal to noise Ratio (ISO 15739) - Dynamic Range - Depth of Field - Geometric Distortion - Image Intensity Uniformity - Color performance - System Functional Testing {8} - Performance characteristics such as leaking, irrigation, bending, articulating bending angle, endurance of bending section, instrument and accessory compatibility, and bending section radius. ## Verification in Differences of Design Scope Adapter – Evaluation of the LumiRex Bronchoscope for Reprocessing, Software, Electrical Safety, Electromagnetic Compatibility, and System Functional Testing, FDA Guidance Document - Electromagnetic Compatibility (EMC) of Medical Devices (June 6, 2022) – Section J – Common Electromagnetic (EM) Emitters, and IEEE/ANSI C63.27-2021 demonstrated that the device in design of the subject device in use wired/wireless scope adapters met requirements in the referenced standards and/or matched the performance of the predicate device. The results met the requirements defined in the standard and/or matched the performance of the predicate device. Insertion Tube – To verify the design of the maneuverable portion, performance characteristic testing and testing per ISO 8600-1:2015 was performed. The bending performance of the LumiRex Bronchoscope met the requirements defined in the standard. Image and Optical Characteristics - To verify the image and optical performance of the LumiRex Bronchoscope, comparative testing was performed between the predicate and subject device for Camera Image Quality, and Determination of Field of View and Direction of View (ISO 8600-3:2019). The results met the requirements defined in the standard and demonstrated substantially equivalent performance to the predicate device. ## 9. Conclusions The subject device LumiRex Bronchoscope is substantially equivalent to predicate device, Vathin Video Bronchoscope System.