Bronchoscope System

K222910 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · EOQ · Apr 11, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K222910
• Device Name: Bronchoscope System
• Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Apr 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

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 Bronchoscope is a single-use device designed for use in adults.

Device Story

Bronchoscope System consists of single-use flexible bronchoscopes (models BR-M58, BR-M52, BR-M50, BR-M40, BR-M32, BR-M22) and a reusable Image Processor (VLM-02). Device used in hospital environments by clinicians for airway/tracheobronchial tree endoscopy. Distal tip contains LED light source and CMOS image sensor; light reflects from cavity, captured by sensor, and transmitted as RGB video signal to Image Processor. Processor handles image processing and outputs video to monitor; allows screenshot/video recording. System aids visualization for diagnostic or therapeutic procedures. Benefits include single-use sterility, reducing cross-contamination risk, and maneuverable tip for navigation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including optical performance (ISO 8600), color reproduction, geometric distortion, resolution, SNR, dynamic range, mechanical testing (suction, bending), electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1).

Technological Characteristics

Flexible bronchoscope with CMOS sensor and LED illumination. Materials comply with ISO 10993-1. Sterilized via Ethylene Oxide (ISO 11135). Reusable Image Processor. Connectivity includes external monitor output and SD card storage. Electrical safety per ANSI AAMI ES60601-1 and IEC 60601-2-18. Shelf life 3 years (ASTM F1980-16).

Indications for Use

Indicated for use in adults for endoscopy within the airways and tracheobronchial tree in a hospital environment, utilizing the Image Processor and ancillary equipment.

Regulatory Classification

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.

Predicate Devices

• Ambu® aScope™ 3, Ambu® aView™ Monitor (K173727)

Reference Devices

• Video Bronchoscope System (K213782)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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) | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [e-mail] Tel: [phone]

#### 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: [e-mail] Tel: [phone]

| Trade/Device Name | Bronchoscope System |
|-------------------|-------------------------------------------------------------------------------------------------------|
| Model | Single-use Bronchoscope:BR-M58, BR-M52, BR-M50, BR-<br>M40, BR-M32, BR-M22<br>Image 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

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.

| System name | Component name | Model |
|------------------------|-------------------------|---------------------------------------------------|
| Bronchoscope<br>System | Single-use Bronchoscope | BR-M58, BR-M52, BR-M50, BR-M40,<br>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 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

#### 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 HugeMed<br>Medical Technical<br>Development Co., Ltd. | Ambu Inc. | / |
| Model | Single-use<br>Bronchoscope:BR-M58,<br>BR-M52, BR-M50, BR-<br>M40, BR-M32, BR-M22<br>Image Processor: VLM-02 | Ambu® aScope™ 3<br>Broncho System:<br>Ambu® aScope™ 3<br>Broncho Slim<br>3.8/1.2<br>Ambu® aScope™ 3<br>Broncho Regular<br>5.0/2.2<br>Ambu® aScope™ 3<br>Broncho Large<br>5.8/2.8<br>Ambu® aView™<br>Monitor | / |
| Classification<br>Name | Bronchoscope (flexible or<br>rigid) and accessories | Bronchoscope (flexible<br>or rigid) and<br>accessories | / |
| Device trade<br>name | Bronchoscope System | Ambu® aScope™ 3<br>Broncho Slim<br>3.8/1.2; Ambu®<br>aScope™ 3 Broncho<br>Regular 5.0/2.2;<br>Ambu® aScope™ 3<br>Broncho Large 5.8/2.8;<br>Ambu® aView<br>Monitor | / |
| Product Code | EOQ | EOQ | Same |
| Indication for<br>use | The Single-use<br>Bronchoscope have been<br>designed to be used with<br>the Image Processor | The aScope 3 Broncho<br>endoscopes have been<br>designed to be used<br>with the aView monitor | Same |
| Features | Subject Device | Predicate Device | Comparison |
| | endotherapy accessories<br>and other ancillary<br>equipment for endoscopy<br>within the airways and<br>tracheobronchial tree.<br>The Bronchoscope<br>System is for use in a<br>hospital environment. The<br>Single-use Bronchoscope<br>is a single-use device<br>designed for use in adults. | endotherapy accessories<br>and other ancillary<br>equipment for<br>endoscopy within the<br>airways and<br>tracheobronchial tree.<br>The aScope 3 system<br>Broncho system are for<br>use in a hospital<br>environment.<br>The aScope 3 Broncho<br>are single-use devices<br>designed for use in<br>adults. | |
| Population | Adults | Adults | Same |
| Anatomic sites | airways and<br>tracheobronchial tree | airways and<br>tracheobronchial tree | Same |
| Rx only | Yes | Yes | Same |
| Technology | The Flexible<br>bronchoscope is inserted<br>through the airways and<br>tracheobronchial tree<br>during Bronchoscopy.<br>Anatomical images are<br>transmitted to the user by<br>the video processor with a<br>CMOS chip at the distal<br>end of the endoscope and<br>the images showing on a<br>monitor. | The Flexible<br>bronchoscope is<br>inserted through the<br>airways and<br>tracheobronchial tree<br>during Bronchoscopy.<br>Anatomical images are<br>transmitted to the user<br>by the video processor<br>with a CMOS chip at<br>the distal end of the<br>endoscope and the<br>images showing on a<br>monitor. | Same |
| Connect to<br>devices | Monitor | Monitor | Same |
| Performance | Complies with: ISO 8600 | Complies with: ISO<br>8600 | Same |
| Field of view<br>(degree) | $120°±10%$ | $85°$ | Different |
| Direction of<br>view (degree) | $0°±10°$ | $0°$ | Same |
| Features | Subject Device | Predicate Device | Comparison |
| Depth of view | 3-50mm | 8-19 mm | Different |
| Working length<br>(mm) | 600mm±10% | 600mm | Same |
| Maximum<br>insertion portion<br>width | BR-M22: 2.2±10%mm<br>BR-M32: 3.2±10%mm<br>BR-M40: 4.4±10%mm<br>BR-M50: 5.0±10%mm<br>BR-M52: 5.2±10%mm<br>BR-M58: 5.8±10%mm | aScope™ 3 Slim<br>4.3mm<br>aScope™ 3 Regular<br>5.5mm<br>aScope™ 3 Large<br>6.3mm | Different |
| Minimum<br>instrument<br>channel width | BR-M22: not applicable<br>BR-M32: 1.2mm<br>BR-M40: ≥1.1mm<br>BR-M50: 2.8mm<br>BR-M52: ≥2.1mm<br>BR-M58: ≥2.5mm | aScope™ 3 Slim<br>1.2mm<br>aScope™ 3 Regular<br>2.2mm<br>aScope™ 3 Large<br>2.8mm | Different |
| Luer/Luer lock<br>connection to<br>working channel | No | Yes | Same as<br>K213782<br>reference<br>device<br>without the<br>luer lock<br>connection |
| Deflection angle | 180° upward and 180°<br>downward | aScope™ 3 Slim:<br>130°up 130°down<br>aScope™ 3 Regular:<br>150°up 130°down<br>aScope™ 3 Large:<br>140°up 110°down | Same as<br>K213782<br>reference<br>device with<br>the 180°<br>deflection<br>angle |
| Digital video<br>technology | CMOS | CMOS | Same |
| Illumination<br>source | LED | LED | Same |
| Separate<br>monitor | Yes | Yes | Same |
| Energy<br>used/power<br>source | Yes | Yes | Same |
| Image/Video<br>capture | Yes | Yes | Same |
| Features | Subject Device | Predicate Device | Comparison |
| Storage | Yes<br>SD Card | Yes<br>SD Card | Same |
| Disposable after use | Single-use Bronchoscope: Yes<br>Image Processor:<br>Reusable | aScope™ 3: Yes<br>aView™: 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:<br>3 Years<br>Comply with ASTM<br>F1980-16 | aScope™ 3: 3 Years<br>Comply with ASTM<br>F1980-16 | Same |
| Electrical<br>Performance | Comply with<br>ANSI AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009(R)2012 and A2:<br>2010/(R)2012<br>IEC 60601-1-2: 2014<br>IEC 60601-2-18:2009 | Comply with<br>ANSI AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009(R)2012 and<br>A2: 2010/(R)2012<br>IEC 60601-1-2: 2014<br>IEC 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:

1. Optical performance testing according to ISO 8600 series.

2. 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.