The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

Device Description

The Bronchoscope System comprises two components: (1) a Portable Video Processor (model: EA101) and (2) a compatible Flexible Bronchoscope (model: BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US).
The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor.
The Flexible Bronchoscope has following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
CMOS Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
For single use
Portable Video Processor has following physical and performance characteristics:
Displays the image from the Flexible Bronchoscope on the built-in screen.
Can be connected to an external monitor.
Non-sterile Reusable device.

AI/ML Overview

The provided 510(k) clearance letter and summary for K243497 indicate that the device in question is a Flexible Bronchoscope System. This submission appears to be a change to an already cleared flexible bronchoscope (K211169) to make it compatible with a new Portable Video Processor (EA101).

Crucially, there is no mention of any AI or machine learning component in the device description, indications for use, or the non-clinical and/or clinical tests summary. The document describes standard performance testing for medical devices, focusing on electrical safety, EMC, photobiological safety, optical performance, biocompatibility, sterilization, shelf life, and package validation. Software verification and validation are mentioned in the context of IEC 62304, which covers medical device software lifecycle processes, but this does not imply AI.

Therefore, many of the questions related to AI-specific acceptance criteria, study methodologies (like MRMC studies, standalone AI performance), ground truth establishment for AI training/testing sets, and expert involvement for AI adjudication are not applicable to the information provided in this document.

The document does provide information relevant to the overall device's performance validation, which can be presented as acceptance criteria and proof for a non-AI medical device.

Non-AI Device Acceptance Criteria and Study Proof

Since the device described is not an AI/ML device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of regulatory clearance for a traditional medical device rather than for AI performance. The studies performed are primarily bench testing and phantom/component level evaluations to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards and demonstration of equivalent performance to a predicate device. The "reported device performance" is the evidence presented to show this compliance.

Acceptance Criterion	Reported Device Performance (Summary from K243497)
Electrical Safety	In compliance with ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
Electromagnetic Compatibility (EMC)	In compliance with ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021] and IEC 60601-2-18 Edition 3.0 2009-08, IEC/TR 60601-4-2 Edition 1.0 2016-05
Photobiological Safety	Tested according to IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.
Optical Performance	Designed to comply with applicable parts of ISO 8600. Optical measurements performed according to applicable parts of ISO 8600 standard. Comparative testing performed for image quality parameters (direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Distortion, Image intensity uniformity) against predicate device.
Biocompatibility	Performed according to ISO 10993-1 and FDA Guidance. Tests conducted: Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity.
Sterilization Efficacy	Validated to ISO 11135:2014. EO/ECH residual test per ISO 10993-7:2008.
Shelf Life	Determined based on stability study including accelerated aging per ASTM F1980-21.
Package Integrity	Validated per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15. Transport and shipping testing per ASTM D4169-22.
Software Verification & Validation	Conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Equivalence to Predicate Device (Flexible Bronchoscope)	Flexible Bronchoscopes are the same as cleared in K211169, with changes related to compatibility with new video processor and package configuration. Other performance data from K211169 is applicable.
Equivalence to Predicate Device (Portable Video Processor)	Demonstrated through comparison of technological characteristics and performance testing to show substantial equivalence. Key differences (IV pole mount, built-in screen, battery power, no USB) were addressed.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Sizes: Not explicitly stated as "sample sizes" in the manner of a clinical trial. For bench testing (electrical safety, EMC, optical, biocompatibility, sterilization, shelf life, packaging), samples of the device and/or its components were tested to meet specific standard requirements. For example, biocompatibility involves testing material extracts, and sterilization validation involves processing batches of devices. The exact number of units tested for each specific bench test is not detailed in this summary.
Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given the applicant is in Shanghai, China, it is highly likely the testing was conducted in China. These were non-clinical bench tests, not clinical studies collecting patient data, so "retrospective or prospective" doesn't directly apply in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of AI/ML ground truth. For traditional device validation, "ground truth" is established by the specifications in recognized consensus standards (e.g., ISO, ASTM, IEC) and the performance characteristics of the predicate device. Expert involvement would be in the form of engineers, test technicians, and quality assurance personnel who perform and verify the tests according to established protocols and standards. Their qualifications are inherent in their professional roles, but not quantified as "number of experts" for ground truth establishment as would be done for clinical image annotation.

4. Adjudication Method for the Test Set

Not applicable in the context of AI/ML adjudication. For traditional device testing, the "adjudication" is compliance with objective, measurable parameters defined by standards. Test results either meet the specified limits/criteria or they do not. QA processes would review and approve test reports, but there isn't a human "adjudication" process in the way it's used for clinical data interpretation differences.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML device. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved and needs to be evaluated for improvement with or without AI assistance. This device is a bronchoscope system for visualization and intervention, not for diagnostic image interpretation by humans that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

No. This is not an AI/ML device. Standalone performance is relevant for AI algorithms. The performance of this device is assessed through its physical, electrical, and optical properties as a medical instrument.

7. The Type of Ground Truth Used

For this traditional medical device, "ground truth" equates to compliance with recognized industry standards and the specifications / validated performance of the predicate device. For example:
- Electrical Safety: Ground truth is defined by the limits and test methods of IEC 60601-1.
- Biocompatibility: Ground truth is established by the accepted biological responses defined in ISO 10993 series.
- Optical Performance: Ground truth is established by the parameters defined in ISO 8600 and comparative measurements against the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI/ML model; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML model or training set, this question is not relevant.

Summary

FDA 510(k) Clearance Letter - K243497

Page 1

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

Doc ID # 04017.07.05

May 29, 2025

Shanghai AnQing Medical Instrument Co., Ltd.
Shuwen Fan
RA Manager
3 & 4 Floor, No.2 Building, 366 Huiqing Rd
East Zhangjiang High-Tech Park
Shanghai, 201201
China

Re: K243497
Trade/Device Name: Portable Video Processor (EA101), Flexible Bronchoscope (BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US)
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: April 28, 2025
Received: April 28, 2025

Dear Shuwen Fan:

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

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K243497 - Shuwen Fan
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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" (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

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K243497 - Shuwen Fan
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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).

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243497

Device Name
Portable Video Processor (EA101);
Flexible Bronchoscope (BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US)

Indications for Use (Describe)
The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k)#: K243497

510(k) Summary

Prepared on: 2025-04-30

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Shanghai AnQing Medical Instrument Co., Ltd.
Applicant Address	3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East Zhangjiang High-Tech Park Shanghai 201201 China
Applicant Contact Telephone	+86-21-61117375
Applicant Contact	Ms. Shuwen Fan
Applicant Contact Email	ra_dept@anqing-sh.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name	Portable Video Processor (EA101); Flexible Bronchoscope (BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US)
Common Name	Bronchoscope (flexible or rigid) and accessories
Classification Name	Bronchoscope (Flexible Or Rigid)
Regulation Number	874.4680
Product Code(s)	EOQ

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K211169	Bronchoscope System	EOQ

Device Description Summary

21 CFR 807.92(a)(4)

The Flexible Bronchoscopes are the same devices as cleared in K211169, except the following changes:

The bronchoscopes are now also compatible to Portable Video Processor.
Package configuration change.

The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor.

The Flexible Bronchoscope has following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
CMOS Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
For single use

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Portable Video Processor has following physical and performance characteristics:

Displays the image from the Flexible Bronchoscope on the built-in screen.
Can be connected to an external monitor.
Non-sterile Reusable device.

Mechanism of action:
The light emitted by the LED cold light source at the distal tip of the endoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Portable Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the build in monitor or attached external monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use are the same.

Technological Comparison

21 CFR 807.92(a)(6)

The Bronchoscope System comprises two components: (1) a Portable Video Processor and (2) a compatible Flexible Bronchoscope.

The subject Flexible Bronchoscopes are the same device as cleared in K211169, except the following changes:

The bronchoscopes are now also compatible to Portable Video Processor.
Package configuration.

The subject device Portable Video Processor (EA101) and and its predicate device, the Video Processor (EOS-H-01), have the following same technological characteristics:
• Both are displaying live video-imaging data of the connected endoscope to a monitor
• Both provide video output formats, recording and data storage functions.
• Both share certain technical functionality such as brightness control, image scaling up/down, white balance manually.

The differences between the subject device Portable Video Processor (EA101) and the predicate device are as follows:
• Portable Video Processor can be hung on an IV pole by means of a bracket.
• Portable Video Processor has a built-in LCD screen that provides live imaging data in addition to the possibility to connect to an external monitor.
• Portable Video Processor can be powered through a Lithium-ion battery.
• Portable Video Processor does not have USB port. There is no data exchange functions available for the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

1. Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
• ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
• ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021]
• IEC 60601-2-18 Edition 3.0 2009-08
• IEC/TR 60601-4-2 Edition 1.0 2016-05

2. Photobiological safety
The proposed device was tested according to the following FDA recognized standards:
• IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems

3. Optical Performance
The proposed device was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.

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In addition, comparative testing related to image quality parameters including direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Distortion,and Image intensity uniformity was performed for proposed device and the predicate device to support substantial equivalence.

Other performance data of the Flexible Bronchoscope cleared via K211169 is applicable.

4. The biocompatibility evaluation for the patient contacting components of the proposed device was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted: Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity.

5. Sterilization and shelf life testing
The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.
EO/ECH residual test was performed according to ISO 10993-7:2008.
The shelf life of the proposed device is determined based on stability study which includes aging test according to ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier.

6. Package Validation
Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-21, ASTM F1929-15. Transport and shipping testing as per ASTM D4169-22.

7. Software
Software verification and validation were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Not Applicable.

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Bronchoscope System is as safe, as effective, and performs as well as the legally marketed device identified above.

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.