Bronchoscope System

K231107 · Hunan Endoso Life Technology Co., Ltd. · EOQ · Feb 15, 2024 · Ear, Nose, Throat

Device Facts

• Record ID: K231107
• Device Name: Bronchoscope System
• Applicant: Hunan Endoso Life Technology Co., Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Feb 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the arways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a disposable device designed for use in adults.

Device Story

Bronchoscope System comprises sterile, single-use flexible video bronchoscope and reusable monitor; used in hospital environments by trained physicians. Distal tip LED illuminates cavity; reflected light captured by CMOS sensor. CMOS drive circuit controls acquisition; RGB video signal transmitted via VI circuit to monitor. Monitor processes video signals for display and controls LED brightness. System facilitates visualization of airways and tracheobronchial tree during bronchoscopy; supports use of endotherapy accessories. Provides real-time anatomical imaging to assist clinical decision-making during endoscopic procedures; disposable nature eliminates reprocessing requirements, reducing cross-contamination risk.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including optical performance (ISO 8600), mechanical characteristics, photobiological safety, color reproduction, SNR, dynamic testing, biocompatibility (cytotoxicity, sensitization, irritation, pyrogen, acute systemic toxicity), and electrical/EMC safety (IEC 60601-1, 60601-2-18, 60601-1-2).

Technological Characteristics

Flexible video bronchoscope with CMOS imager and internal LED light source. Materials: Pebax, polyamide, stainless steel, epoxy glue, glass, polycarbonate, PTFE, PET. Connectivity: MIPI video interface to monitor. Sterilization: EO (SAL 10^-6). Software: Moderate level of concern. Standards: ISO 8600 (optical), ISO 10993-1 (biocompatibility), IEC 60601 series (safety/EMC), ISO 11135 (sterilization), ISO 11607 (packaging).

Indications for Use

Indicated for use in adults for endoscopic procedures within the airways and tracheobronchial tree, utilizing the Bronchoscope System in a hospital environment.

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

• Vathin® Video Bronchoscope System (K191828)

Submission Summary (Full Text)

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 15, 2024

Hunan Endoso Life Technology Co., Ltd. % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai, 200072 China

Re: K231107

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: EOQ Dated: January 16, 2024 Received: January 17, 2024

Dear Kyra Kang:

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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(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 OS 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 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-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 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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.

Shuchen Peng -S

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

510(k) Number (if known) K231107

Device Name Bronchoscope System

Indications for Use (Describe)

The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the arways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.

The Single-use Bronchoscope is a disposable device designed for use in adults.

Type of Use (Select one or both, as applicable)

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

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## 510(k) Summary

| Date Prepared: | February 13, 2024 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd.<br>The 4th floor, Building 10, Innovation and<br>Entrepreneurship Center, No. 31, Dongfeng Road,<br>Economic and Technological Development Zone,<br>Xiangtan, Hunan Province 411200, P. R. China |
| Contact Person: | Wang Fu<br>RA Manager<br>Hunan Endoso Life Technology Co., Ltd.<br>Tel: [phone]<br>Email: [e-mail]<br>Or [e-mail] |
| Submission Correspondent: | Ms.Kyra Kang<br>Landlink Healthcare Technology (Shanghai) Co.,<br>Ltd.<br>Email: [e-mail] |
| Identification of the Device: | |
| Proprietary/Trade Name: | Single-use Bronchoscope, Monitor for Single-Use<br>Endoscopy, Bronchoscope System |
| Model: | Single-use bronchoscope: BC12-1, BC12-2,<br>BC20-1, BC20-2, BC22-1, BC22-2, BC22-3,<br>BC28-1, BC28-2, BC28-3<br>Monitor for Single-Use Endoscopy:<br>P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C,<br>P2-D, P2-E |
| Common or Usual Name: | Bronchoscope (flexible or rigid) and accessories |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories<br>(21 CFR 874.4680) |
| Product Code: | EOQ |
| Device Class: | Class II |

# Identification of the Legally Marketed Predicate Device:

| Trade Name: | Vathin® Video Bronchoscope System |
|--------------------------|-----------------------------------------------------------------------|
| Classification Name: | Bronchoscope (flexible or rigid) and accessories<br>(21 CFR 874.4680) |
| Product Code: | EOQ |
| Device Class: | Class II |
| Submitter/510(k) Holder: | Hunan Vathin Medical Instrument Co., Ltd. |

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Clearance:

#### K191828

This predicate has not been subject to a design-related recall.

#### Device Description:

The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.

The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the disposable video 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 Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.

#### Indications for Use:

The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, 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 disposable device designed for use in adults.

## Substantial Equivalence:

The Bronchoscope System employs the same fundamental scientific technology as its predicate device, as below table:

| | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| K Number | K231107 | K191828 | |
| | Single-use Bronchoscope: | Vathin®H-SteriScope™ I<br>Single-use flexible Video<br>Bronchoscope: | |
| Model | BC12-1, BC12-2, BC20-1,<br>BC20-2, BC22-1, BC22-2,<br>BC22-3, BC28-1, BC28-2, | BCV1-01 BCV1-02<br>BCV1-C1 BCV1-C2 | / |
| | Subject Device | Predicate Device | Comparison |
| K Number | K231107 | K191828 | |
| | BC28-3 | BCV1-H1 BCV1-H2 | |
| | Monitor for Single-Use<br>Endoscopy :<br>P1-A, P1-B, P1-C, P1-D,<br>P1-E, P2-A, P2-B, P2-C,<br>P2-D, P2-E | BCV1-K1 BCV1-K2<br>BCV1-M1 BCV1-M2<br>BCV1-O1 BCV1-O2<br>BCV1-S1 BCV1-S2<br>BCV1-U1 BCV1-U2<br>BCV1-W1 BCV1-W2<br>Vathin®VisionCenter™ I<br>Digital Video Processor:<br>DVP-A1 | |
| Manufacturer | Hunan Endoso Life<br>Technology Co., Ltd. | Hunan Vathin Medical<br>Instrument Co., Ltd. | / |
| Classification<br>Name | Bronchoscope (flexible or<br>rigid) and accessories | Bronchoscope (flexible or<br>rigid) and accessories | / |
| Product Code | EOQ | EOQ | / |
| Indications<br>For Use: | The Single-use<br>Bronchoscope have been<br>designed to be used with the<br>Monitor for Single-Use<br>Endoscopy, endotherapy<br>accessories and other<br>ancillary equipment for<br>endoscopy within the<br>airways and<br>tracheobronchial tree. The<br>Bronchoscope System is for<br>use in a hospital<br>environment.<br>The Single-use<br>Bronchoscope is a<br>disposable device designed<br>for use in adults. | The Vathin®H-SteriScopeᵀ<br>M I Single-use flexible<br>Video Bronchoscope have<br>been designed to be used<br>with the Vathin® Vision<br>Center™ I Digital Video<br>Processor,<br>endotherapy accessories<br>and other ancillary<br>equipment for endoscopy<br>within the airways and<br>tracheobronchial tree.<br>The Vathin® Video<br>Bronchoscope System is<br>for use in a hospital<br>environment. | Similar¹ |
| Working<br>place/User | Use in a hospital<br>environment by trained<br>surgical physicians who are<br>familiar with endoscopic<br>procedures. | Use in a hospital<br>environment by trained<br>surgical physicians who<br>are familiar with<br>endoscopic procedures. | Same |
| Population | Adults | Adults | Same |
| Technology | The Single-use | The Flexible bronchoscope | Same |
| | Subject Device | Predicate Device | Comparison |
| K Number | K231107 | K191828 | |
| | bronchoscope is inserted<br>through the airways and<br>tracheobronchial tree during<br>Bronchoscopy. Anatomical<br>images are transmitted to the<br>user by the Monitor for<br>Single-Use Endoscopy with<br>a CMOS chip at the distal<br>end of the endoscope and<br>the images showing on the<br>monitor. | is inserted through the<br>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. | |
| | Physical Characteristics | | |
| Type of Scope | Flexible | Flexible | Same |
| Distal end<br>outer diameter | ≤2.9mm (8.7 Fr) | ≤3.1mm (9.3 Fr) | Similar2 |
| Insertion<br>Section length | 600mm | 600/700mm | Similar3 |
| | Optical Characteristics | | |
| Type of<br>Imager | CMOS | CMOS | Same |
| Direction of<br>View | forward | forward | Same |
| Depth of Field | 3mm~50mm | 3mm~30mm | Similar4 |
| Light Source | Internal LED | Internal LED | Same |
| | Patient Contacting Materials | | |
| General<br>material type<br>of main<br>patient-contact<br>part | Pebax, polyamide, Stainless<br>Steel, Epoxy glue, glass,<br>Polycarbonate, PTFE, PET | Pebax, PTFE, LCP, TPU,<br>Fluoro elastomers,<br>Epoxy glue, glass | Different5 |
| Duration and<br>type of contact | "Surface -Mucosal<br>Membrane" with a contact<br>duration of "Limited (< 24<br>hours)" | "Surface -Mucosal<br>Membrane" with a contact<br>duration of "Limited (< 24<br>hours)" | Same |
| Other information | | | |
| Number of<br>Uses | Single-Use | Single-Use | Same |
| Sterilization | EO Sterilized,<br>SAL 10 | EO Sterilized,<br>SAL 10-6 | Same |
| | Subject Device | Predicate Device | Comparison |
| K Number | K231107 | K191828 | |
| Video format inputs (Camera) | MIPI | DVI/USB | Different6 |
| Storage | Yes SD Card | Yes SD Card | Same |
| Image/Video Capture | Yes | Yes | Same |
| Single use/reusable | Single-use for bronchoscope/ reusable for Monitor for Single-Use Endoscopy | Single-use for bronchoscope/ reusable for Video Processor | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same |
| | No Irritation to Skin | No Irritation to Skin | Same |
| | No significant evidence of sensitization | No significant evidence of sensitization | Same |
| | No pyrogen | No pyrogen | Same |

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Analysis 1:

Only different expressions.

Analysis 2:

The thinner the outer diameter, the less damage it will cause to the patient after being inserted into the trachea; The thinner the outer diameter, the stronger the patient's comfort; The thinner the outer diameter, the easier it is for doctors to insert into the affected area of the trachea. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.

Analysis 3:

The insertion section length of subject device is covered by the predicate device.

Analysis 4:

The optical performance of the subject device was tested and the results met the ISO 8600 series, this difference will not raise any issues in safety and effectiveness.

Analysis 5:

Biocompatibility of the Single-use Bronchoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, this difference will not raise any issues in safety and effectiveness.

Analysis 6:

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MIPI, DVI, and USB are all intermediate formats for data transmission, which ultimately display images on the display screen. What users see is an image, so this difference is only a difference in data transmission format, not functional performance, and does not affect safety and effectiveness.

#### Summary of Testing:

#### Summary of Non-Clinical Tests:

## Electrical Safety and Electromagnetic Compatibility Summary

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.

#### Bench Testing Summary

The following bench tests were performed:

- Optical performance testing according to ISO 8600 series. 1.
- Mechanical characteristics were performed compared with the predicate device. 2.
- Color feature separation and photobiological safety test. 3.
- Color performance (color reproduction), optical performance (resolution, depth of 4. view and image intensity uniformity), SNR and dynamic test compared with the predicate device.

#### Biocompatibility Summary

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
- Intracutaneous reactivity/irritation
- Pyrogen
- · Acute systemic toxicity

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

#### Sterilization and shelf life testing

The sterilization method has been validated according to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Single-use Bronchoscope is validated.

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## 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.

#### Cybersecurity

Cybersecurity was conducted according to FDA's Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

## Clinical Testing

Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.

## Package Validation

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-15, ASTM F 1929-15. Transport and shipping testing as per ASTM D4169-16.

#### Conclusion:

The non-clinical testing demonstrates that the subject device is as safe, as effective and performs as well as the predicate device. The Bronchoscope System is substantially equivalent to the predicate device.