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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) clearance letter and a 510(k) Summary for the LumiRex Bronchoscope. While it details numerous non-clinical validation tests (sterilization, biocompatibility, software, cybersecurity, electrical safety, wireless latency, and various bench tests related to mechanical and optical performance), it does not include information about an AI component or a study proving device performance against acceptance criteria for an AI algorithm.

The document focuses on the equivalence of the LumiRex Bronchoscope as a physical medical device (endoscope with camera) to a predicate device. It describes its mechanical and optical functions, wireless capabilities, and basic image display. There is no mention of an algorithm or AI specifically designed to interpret or analyze images for diagnostic or assistive purposes, which would typically be the focus of the "acceptance criteria and study" described in your prompt.

Therefore, I cannot create the table or answer the specific questions related to an AI algorithm's acceptance criteria and performance study based on the provided text. The information simply isn't present in this 510(k) submission summary.

If this was a misunderstanding and you were expecting information about the bronchoscope's general performance acceptance criteria, I can provide a general interpretation based on the bench testing listed, but it would not involve the AI-specific details you requested.

For example, if we were to infer "acceptance criteria" from the bench testing section without an AI component, it would look something like this:

Inferred Acceptance Criteria for LumiRex Bronchoscope (Non-AI)

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Sterilization & Shelf-Life	Evaluated to ISO 11135:2014 (Sterilization), ISO 11607-2:2019 and ASTM F1980 (Sterile Barrier), and validated for shelf-life.
Reprocessing	Evaluated per FDA Guidance, AAMI TIR12:2020, AAMI/ANSI/ISO 11737-1:2018, ANSI/AAMI ST79:2017, ANSI/AAMI/ISO 17665-1:2006/(R)2013, AAMI ST98:2022.
Biocompatibility	Evaluated to ISO 10993-1 (FDA Guidance), covering Cytotoxicity (10993-5:2009), Sensitization (10993-10:2021), Systemic Toxicity (10993-11:2017), Pyrogenicity (10993-11:2017), Irritation (10993-23:2021).
Software	Verification and validation testing conducted in compliance with IEC 62304, ANSI/AAMI/IEC ES60601-1, and FDA guidance documents ("General Principles of Software Validation," "Premarket Submissions for Device Software Functions").
Cybersecurity	Evaluated in conformance to "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Electrical Safety & EMC	Undergone testing complying with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.
Wireless Performance (Latency)	Latency tested referring to "Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff." Latency comparable between wired and wireless modes and within acceptance range.
Mechanical Connectivity	Bench tested to ISO 80369-7:2021 (Small-bore Connectors).
General Endoscope Requirements	Bench tested to ISO 8600-1:2015 (General Requirements).
Optical - Field & Direction of View	Bench tested to ISO 8600-3:2019. Comparative testing showed wider field of view and larger depth of view than predicate. Results met standard requirements and showed substantial equivalence.
Mechanical - Insertion Portion Width	Bench tested to ISO 8600-4:2014.
Photobiological Safety	Bench tested to IEC 62471:2006.
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. Comparative testing showed results met standard requirements and demonstrated substantial equivalence to predicate.
System Functional Testing	Leaking, irrigation, bending, articulating bending angle, endurance of bending section, instrument and accessory compatibility, bending section radius. Performance characteristics met defined requirements.
Maneuverability (Bending Performance)	Tested per ISO 8600-1:2015. Met specified requirements. (Smaller insertion tube bend radius than predicate.)
Image Controls	Automated White balance, no image enhancement control. Simplifies UI, no new risks.
Video Format Compatibility	Different input/output formats from predicate, but VPU processes and displays similarly to predicate. No new risks.

Regarding the other questions:

Sample size for the test set and data provenance: Not applicable or not specified for an AI algorithm evaluation. The document discusses bench testing of physical characteristics, not a clinical test set of patient data for algorithm performance.
Number of experts used to establish ground truth: Not applicable, as there's no AI component or clinical ground truth established for an algorithm.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not mentioned and not typically performed for a purely hardware device without an AI interpretive component.
Standalone (algorithm only) performance: Not applicable, as no algorithm is described.
Type of ground truth used: Not applicable, as no AI algorithm requiring ground truth is described.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

In summary, the provided 510(k) documentation focuses on the substantial equivalence of "LumiRex Bronchoscope" as a medical device to a predicate based on its mechanical, electrical, software validation (for device operation, not AI), and optical characteristics, but does not contain information related to artificial intelligence performance studies.

Summary

FDA 510(k) Clearance Letter - LumiRex Bronchoscope

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

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"

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K243541 - John O'Conner
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(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).

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K243541 - John O'Conner
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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

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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)

LumiRex Bronchoscope
Page 12 of 90

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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

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

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endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.

6. Indications for Use Comparison

The subject device LumiRex Bronchosope 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.

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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)

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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

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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.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.