The Single-use Bronchoscope have been designed to be used with the Image 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 Single-use is a single-use device designed for use in adults.

Device Description

The Bronchoscope System consists of Single-use Bronchoscope (six models shown in below) to be introduced within the airways or tracheobronchial tree and Image Processor (model: VLM-02) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Image Processor provides power and processes the images for medical electronic endoscope.

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Image Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope 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 Image Processor via the VI circuit. The Image Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Image Processor also controls the brightness of the LEDs on the endoscope.

The optical components and their arrangement at the distal tip for all models of the Singleuse Bronchoscope are identical.

Single-use Bronchoscope has the following physical and performance characteristics:

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

Image Processor has the following physical and performance characteristics:

Display the image from the Single-use Bronchoscope on the screen ●
Can record screenshots or video of image from the Single-use Bronchoscope
Can connect to an external monitor ●
Reusable device

AI/ML Overview

The provided text is a 510(k) summary for a Bronchoscope System. It details the device description, indications for use, comparison to a predicate device, and performance data. However, it does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance for an AI/ML device. The document lists bench performance tests according to ISO 8600 series and other parameters, but these are for a standard bronchoscope system, not an AI component.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML component.
Sample size for the training set for an AI/ML component.
How ground truth for the training set was established for an AI/ML component.

The document explicitly states: "No clinical study is included in this submission" (Section 10), and the performance data primarily relates to bench testing, biocompatibility, sterilization, electrical safety, and software verification/validation for the traditional bronchoscope system.

To answer your request for an AI/ML device, I would need a different document that describes such a device and its associated clinical or performance studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

April 11, 2023

Shenzhen HugeMed Medical Technical Development Co., Ltd % Kevin Wang Consultant Shenzhen Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K222910

Trade/Device Name: Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: March 7, 2023 Received: March 8, 2023

Dear Kevin Wang:

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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Image /page/1/Picture/5 description: The image shows the name "Joyce C. Lin -S" in a simple, sans-serif font. The text is black against a white background. The name is written in a clear and legible manner.

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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Indications for Use

510(k) Number (if known)

K222910

Device Name Bronchoscope System

Indications for Use (Describe)

The Single-use Bronchoscope have been designed to be used with the Image 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 Single-use 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)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2023/04/11

1. Submission sponsor

Name: Shenzhen HugeMed Medical Technical Development Co., Ltd. Address: 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, Guangdong Province, 518115, China Contact person: Cathy Title: Regulatory engineer E-mail: cathy.shi@hugemed.cn Tel: +86-755-22275833

2. Submission correspondent

Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160

Trade/Device Name	Bronchoscope System
Model	Single-use Bronchoscope:BR-M58, BR-M52, BR-M50, BR-M40, BR-M32, BR-M22Image Processor: VLM-02
Common Name	Bronchoscope System
Regulatory Class	Class II
Classification	21CFR 874.4680 / Bronchoscope (Flexible or Rigid) / EOQ
Submission type	Traditional 510(K)

3. Subject Device Information

Predicate Device 4.

510(k) number: K173727 Product name: Ambu® aScope™ 3, Ambu® aView™M Monitor Submitter: Ambu Inc.

5. Reference Device

510(k) number: K213782 Product name: Video Bronchoscope System Submitter: Micro-Tech (Nanjing) Co., Lts

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6. Device Description

System name	Component name	Model
BronchoscopeSystem	Single-use Bronchoscope	BR-M58, BR-M52, BR-M50, BR-M40,BR-M32, BR-M22
	Image Processor	VLM-02

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Image Processor is a reusable monitor.

The optical components and their arrangement at the distal tip for all models of the Singleuse Bronchoscope are identical.

Single-use Bronchoscope has the following physical and performance characteristics:

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

Image Processor has the following physical and performance characteristics:

Display the image from the Single-use Bronchoscope on the screen ●
Can record screenshots or video of image from the Single-use Bronchoscope
Can connect to an external monitor ●
Reusable device

Intended use & Indication for use 7.

The Single-use Bronchoscope have been designed to be used with the Image Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways

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and tracheobronchial tree.

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

Features	Subject Device	Predicate Device	Comparison
K number	K222910	K173727	/
Manufacturer	Shenzhen HugeMedMedical TechnicalDevelopment Co., Ltd.	Ambu Inc.	/
Model	Single-useBronchoscope:BR-M58,BR-M52, BR-M50, BR-M40, BR-M32, BR-M22Image Processor: VLM-02	Ambu® aScope™ 3Broncho System:Ambu® aScope™ 3Broncho Slim3.8/1.2Ambu® aScope™ 3Broncho Regular5.0/2.2Ambu® aScope™ 3Broncho Large5.8/2.8Ambu® aView™Monitor	/
ClassificationName	Bronchoscope (flexible orrigid) and accessories	Bronchoscope (flexibleor rigid) andaccessories	/
Device tradename	Bronchoscope System	Ambu® aScope™ 3Broncho Slim3.8/1.2; Ambu®aScope™ 3 BronchoRegular 5.0/2.2;Ambu® aScope™ 3Broncho Large 5.8/2.8;Ambu® aViewMonitor	/
Product Code	EOQ	EOQ	Same
Indication foruse	The Single-useBronchoscope have beendesigned to be used withthe Image Processor	The aScope 3 Bronchoendoscopes have beendesigned to be usedwith the aView monitor	Same
Features	Subject Device	Predicate Device	Comparison
	endotherapy accessoriesand other ancillaryequipment for endoscopywithin the airways andtracheobronchial tree.The BronchoscopeSystem is for use in ahospital environment. TheSingle-use Bronchoscopeis a single-use devicedesigned for use in adults.	endotherapy accessoriesand other ancillaryequipment forendoscopy within theairways andtracheobronchial tree.The aScope 3 systemBroncho system are foruse in a hospitalenvironment.The aScope 3 Bronchoare single-use devicesdesigned for use inadults.
Population	Adults	Adults	Same
Anatomic sites	airways andtracheobronchial tree	airways andtracheobronchial tree	Same
Rx only	Yes	Yes	Same
Technology	The Flexiblebronchoscope is insertedthrough the airways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user bythe video processor with aCMOS chip at the distalend of the endoscope andthe images showing on amonitor.	The Flexiblebronchoscope isinserted through theairways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the userby the video processorwith a CMOS chip atthe distal end of theendoscope and theimages showing on amonitor.	Same
Connect todevices	Monitor	Monitor	Same
Performance	Complies with: ISO 8600	Complies with: ISO8600	Same
Field of view(degree)	$120°±10%$	$85°$	Different
Direction ofview (degree)	$0°±10°$	$0°$	Same
Features	Subject Device	Predicate Device	Comparison
Depth of view	3-50mm	8-19 mm	Different
Working length(mm)	600mm±10%	600mm	Same
Maximuminsertion portionwidth	BR-M22: 2.2±10%mmBR-M32: 3.2±10%mmBR-M40: 4.4±10%mmBR-M50: 5.0±10%mmBR-M52: 5.2±10%mmBR-M58: 5.8±10%mm	aScope™ 3 Slim4.3mmaScope™ 3 Regular5.5mmaScope™ 3 Large6.3mm	Different
Minimuminstrumentchannel width	BR-M22: not applicableBR-M32: 1.2mmBR-M40: ≥1.1mmBR-M50: 2.8mmBR-M52: ≥2.1mmBR-M58: ≥2.5mm	aScope™ 3 Slim1.2mmaScope™ 3 Regular2.2mmaScope™ 3 Large2.8mm	Different
Luer/Luer lockconnection toworking channel	No	Yes	Same asK213782referencedevicewithout theluer lockconnection
Deflection angle	180° upward and 180°downward	aScope™ 3 Slim:130°up 130°downaScope™ 3 Regular:150°up 130°downaScope™ 3 Large:140°up 110°down	Same asK213782referencedevice withthe 180°deflectionangle
Digital videotechnology	CMOS	CMOS	Same
Illuminationsource	LED	LED	Same
Separatemonitor	Yes	Yes	Same
Energyused/powersource	Yes	Yes	Same
Image/Videocapture	Yes	Yes	Same
Features	Subject Device	Predicate Device	Comparison
Storage	YesSD Card	YesSD Card	Same
Disposable after use	Single-use Bronchoscope: YesImage Processor:Reusable	aScope™ 3: YesaView™: Reusable	Same
Components in contact with the patient is delivered sterile	Yes, EO	Yes, EO	Same
Suction possible	Yes	Yes	Same
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	Same
Shelf life	Single-use Bronchoscope:3 YearsComply with ASTMF1980-16	aScope™ 3: 3 YearsComply with ASTMF1980-16	Same
ElectricalPerformance	Comply withANSI AAMI ES60601-1:2005/(R)2012 andA1:2012,C1:2009(R)2012 and A2:2010/(R)2012IEC 60601-1-2: 2014IEC 60601-2-18:2009	Comply withANSI AAMI ES60601-1:2005/(R)2012 andA1:2012,C1:2009(R)2012 andA2: 2010/(R)2012IEC 60601-1-2: 2014IEC 60601-2-18:2009	Same

8. Comparison to the Predicate Device

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Performance Data 9.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Single-use Bronchoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:

Cytotoxicity ●
Sensitization ●

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Intradermal reactivity
The Single-use Bronchoscope is considered surface - mucosal membrane contacting for a duration of less than 24 hours.

Sterilization and shelf life testing

The Single-use Bronchoscope is provided sterile and its shelf-life is 3 years. Sterilization Process has been validated in accordance with ISO 11135:2014.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life is determined based on optical testing and product performance testing after accelerated aging test according to ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F 1929-15.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Bronchoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Bench performance testing

The following bench tests were performed:

Optical performance testing according to ISO 8600 series.
Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device. 3. Mechanical testings including suction and bending testing.

10. Clinical study

No clinical study is included in this submission

11. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.

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.