Broncoflex Agile, Broncoflex Vortex, Screeni

K212886 · Axess Vision Technology · EOQ · Feb 16, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K212886
• Device Name: Broncoflex Agile, Broncoflex Vortex, Screeni
• Applicant: Axess Vision Technology
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Feb 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments. This video-bronchoscope is designed for use exclusively in a hospital environment.

Device Story

System comprises single-use video-bronchoscope (Broncoflex Agile/Vortex) and reusable display monitor (Screeni). Bronchoscope captures pulmonary tract images via distal tip sensor; transmits data to Screeni monitor for real-time visualization. Used in hospital settings by clinicians for airway examination and procedures requiring suction or endotherapy instruments. Screeni features touch interface, internal storage, and HDMI output for secondary display. System aids clinical decision-making by providing direct visual access to airways. Benefits include reduced cross-contamination risk due to single-use bronchoscope design.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), software verification/validation (IEC 62304), biocompatibility, sterile packaging integrity, shelf life, and transportation testing.

Technological Characteristics

Single-use flexible video-bronchoscope; reusable TFT LCD monitor. Bronchoscope: 2 LEDs, 400x400 resolution, ETO sterilization. Screeni: 10.1-inch touch display, 1280x800 resolution, Li-ion battery (3hr life), 16GB storage. Connectivity: USB, HDMI output. Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for adult patients requiring optical visualization of the pulmonary tract and bronchial tree, and for use with endotherapy accessories and instruments. Designed for hospital use only.

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

• Broncoflex Agile, Broncoflex Vortex and Screeni (K202180)

Submission Summary (Full Text)

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February 16, 2022

Axess Vision Technology Marie-Hélène Bacheley Regulatory Affairs and Ouality Assurance Manager Zone de la Liodière 6. rue de la Flottière Joué-lès-Tours, Indre-et-Loire 37300 France

Re: K212886

Trade/Device Name: Broncoflex Agile, Broncoflex Vortex, Screeni Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: October 29, 2021 Received: November 4, 2021

Dear Marie-Hélène Bacheley:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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,

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

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212886

Device Name

Broncoflex® Agile, Broncoflex® Vortex and Screeni®

Indications for Use (Describe) Broncoflex® Agile and Broncoflex® Vortex

This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments.

This video-bronchoscope is designed for use exclusively in a hospital environment.

Endotherapy accessories and instruments

The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope.

| Model | Minimum compatible<br>endotracheal tube size | Minimum compatible dual<br>lumen endo-bronchial tube size | Maximum size of<br>endotherapy instruments |
|-------------------|----------------------------------------------|-----------------------------------------------------------|--------------------------------------------|
| Broncoflex Agile | $\geq 5.0$ mm | $\geq 35$ Fr. | $\leq 1.2$ mm |
| Broncoflex Vortex | $\geq 6.0$ mm | $\geq 41$ Fr. | $\leq 2.6$ mm |

Patient Population

The Broncoflex can only be used on adult patients.

#### Screeni®

This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® video-bronchoscope.

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.

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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.*

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## 510(k) Summary

# Broncoflex® Vortex, Broncoflex® Agile and Screeni® (Flexible Bronchoscope System)

## K212886

### 1. Submitter:

| Submitter's Name: | Axess Vision Technology | |
|------------------------|--------------------------------------------------------------------------------|------------------------------------------------|
| Address: | Zone de la Liodière<br>6 rue de la flottière<br>37300 Joué-lès-Tours<br>France | |
| Contact Person: | Marie-Hélène BACHELEY | Regulatory Affairs & Quality Assurance Manager |
| Address: | Zone de la Liodière<br>6 rue de la flottière<br>37300 Joué-lès-Tours | |
| Phone Number: | [phone] | |
| Fax Number: | NA | |
| Date Summary Prepared: | 20 August 2021 | |

#### 2. Device:

| Name of Device: | Broncoflex® Agile; Product Reference: 20030001<br>Broncoflex® Vortex; Product Reference: 10030001<br>Screeni®; Product Reference: 30030001 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Flexible Bronchoscope |
| Classification Name: | Bronchoscope (Flexible or Rigid) and accessories |
| Regulation Number: | 21 CFR 874.4680 |
| Device Class: | II |
| Product Code: | EOQ |
| Device Panel: | Ear Nose & Throat |

#### 3. Predicate Devices:

Broncoflex® Agile, Broncoflex® Vortex and Screeni® (Broncoflex® Agile or Vortex + Screeni® = the system) are substantially equivalent to the legally marketed predicate devices:

| Manufacturer: | Axess Vision Technology |
|----------------|-----------------------------------------------------|
| Trade Name: | Broncoflex® Agile<br>Broncoflex® Vortex<br>Screeni® |
| 510(K) Number: | K202180 |

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

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#### 4. Device Description:

Broncoflex Agile and Broncoflex Vortex are a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The videobronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni) and to be used with endotherapy accessories and instruments. The applied part of the medical device is the whole of the flexible tubing containing the insertion tube, the articulated section and the distal tip (BF type applied part: BF). Broncoflex is sterile and supplied ready to use in its sealed packaging (sterilization method ethylene oxide). The Screeni is a reusable nonsterile medical device and is a video processor with integrated touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex. The consumables (Broncoflex) are supplied in sets of 5 in a carton. Inside this box, each sterilized consumable is placed in a single sterile pouch. Screeni is supplied in a carton with all the accessories (quick mounting bracket, knurled screw, power supply, EU/US/UK/AU adaptors and video cable (HDMI/DVI)). Broncoflex Agile and Broncoflex Vortex are the same devices except for some dimensional aspects such as external diameter of insertion tube, distal tip outer diameter and working channel inner diameter. Indeed, Broncoflex Agile has an applied part with a smaller diameter than the Broncoflex Vortex.

#### 5. Indications for Use:

#### 1. Broncoflex Agile and Vortex

This video-bronchoscope is intended to prove an optical display of pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments.

This video-bronchoscope is designed for use exclusively in a hospital environment.

#### Endotherapy accessories and instruments

The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope.

| Model | Minimum compatible<br>endotracheal tube size | Minimum compatible<br>dual lumen endo-<br>bronchial tube size | Maximum size of<br>endotherapy instruments |
|-------------------|----------------------------------------------|---------------------------------------------------------------|--------------------------------------------|
| Broncoflex Agile | $\ge$ 5.0 mm | $\ge$ 35 Fr. | $\le$ 1.2 mm |
| Broncoflex Vortex | $\ge$ 6.0 mm | $\ge$ 41 Fr. | $\le$ 2.6 mm |

#### Patient Population

The Broncoflex can only be used on adult patients.

#### 2. Screeni

This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® video-bronchoscope.

#### 6. Comparison of technological characteristics with the predicate device:

#### 1. Broncoflex Agile and Vortex

Broncoflex Agile and Broncoflex Vortex are technologically substantially equivalent to the predicate devices. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

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| Type | Broncoflex® Vortex<br>Subject device | Broncoflex® Agile<br>Subject device | Broncoflex® Vortex<br>Predicate device | Broncoflex® Agile<br>Predicate device |
|-------------------------------------------|--------------------------------------|-------------------------------------|----------------------------------------|---------------------------------------|
| Product reference | 10030001 | 20030001 | 10030001 | 20030001 |
| Field of vision direction | 0° | 0° | 0° | 0° |
| Field angle | 87,5° | 87,5° | 87,5° | 87,5° |
| Field depth | 5 - 50 mm | 5 - 50 mm | 5 - 50 mm | 5 - 50 mm |
| High/low<br>deflection<br>angle | 200°/200° | 220°/220° | 200°/200° | 220°/220° |
| External<br>diameter<br>of insertion tube | 5.4 mm | 3.6 mm | 5.4 mm | 3.6 mm |
| Distal<br>end<br>outer<br>diameter | 5.6 mm | 3.9 mm | 5.6 mm | 3.9 mm |
| Operator channel inner<br>diameter | 2.8 mm | 1.4 mm | 2.8 mm | 1.4 mm |
| Working length | 605 mm | 605 mm | 605 mm | 605 mm |
| Lighting system | 2 LEDs | 2 LEDs | 2 LEDs | 2 LEDs |
| Image resolution | 400x400 | 400x400 | 400x400 | 400x400 |
| Sterilisation | Ethylene oxide | Ethylene oxide | Ethylene oxide | Ethylene oxide |

The Broncoflex Vortex and Broncoflex Agile are the same as the predicate devices in the following areas:

- Bronchoscope used to reach the target organs, tissues and subsystems (pulmonary tract) .
- Device inserted through oral or nasal route .
- Viewing of the upper airways and of the bronchial tree
- Performance of other procedures such as as performing examinations requiring suction of . secretions or the use of endotherapy accessories or instruments designed for use in combination with a bronchoscope
- . Single-use devices provided sterile
- . Field of vision direction
- . Lighting system (2 LEDs)
- . Image resolution
- Sterile with ETO .

#### 2. Screeni

Screeni is technologically substantially equivalent to the predicate device.

| Type | Screeni®<br>Subject device | Screeni®<br>Predicate device |
|---------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Product reference | 30030001 | 30030001 |
| ELECTRICAL CHARACTERISTICS | | |
| Power requirement | 100-240V AC / 50-60Hz / 0.6A | 100 - 240V AC; 50-60Hz; 0.6A |
| Power output | 15 VDC / 2A | 18V DC; 1.67A |
| Type of protection against<br>electrocution | Class 2 | Class 2 |
| Battery type | Lithium-Ion battery (11,25V -<br>2950mAh or 10,8V – 3350mAh) | Lithium-Ion battery (11,25V -<br>2950mAh or 10,8V – 3350mAh) |
| Battery Operation | At least 3 hours (for a new and fully<br>charged battery) | At least 3 hours (for a new and fully<br>charged battery) |
| MECHANICAL CHARACTERISTICS | | |
| Dimensions | L: 300 mm x H: 200 mm x D: 110 mm<br>(mounting bracket folded) | L: 300 mm x H: 200 mm x D: 110 mm<br>(mounting bracket folded) |
| Weight | 1.8 kg (with mounting bracket) | 1.8 kg (with mounting bracket) |
| Mounting interface | VESA 75 mm | VESA 75 mm |

Table 2: Screeni and aViewTechnical Characteristics

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| TOUCH SCREEN | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Resolution | 1280x800 | 800x480 |
| Display type | 10.1-inch TFT LCD | 10.1-inch TFT LCD |
| MISCELLANEOUS CHARACTERISTICS | | |
| IP ProtectionClassification<br>System | IP30 | IP30 |
| Exported file formats | Photos: .JPG<br>Videos: .AVI (h264 compression) | Photos: .JPG<br>Videos: .AVI (h264 compression) |
| TECHNICAL CHARACTERISTICS | | |
| Internal storage capacity | 16 Gb (can store up to 14 h of video or<br>more than 100,000 photos) | 16 Gb (can store up to 14 h of video or<br>more than 100,000 photos) |
| Connections | Type A (for USB key connection only) | Type A (for USB key connection only) |
| | Endoscope port | Endoscope port |
| | DC 15V / 2A input | DC 15V / 2A input |
| | HDMI port: video output to be used with a<br>DVI compatible monitor only and with the<br>HDMI/DVI cable supplied. | NA |

The Screeni is the same as the predicate device in the following areas:

- Viewing of the upper airways and of the bronchial tree ●
- Correct image orientation ●
- . Touch screen
- . Battery time/operation (3 hours)
- Battery type (Lithium-ion) ●
- . Storage capacity
- USB, endoscope and power out (electrical power) connection .

The Screeni is different from the predicate device in the following area:

· HDMI port for use with a DVI compatible monitor and the provided HDMI/DVI cable to duplicate the live image from the endoscope to a secondary monitor

This difference has no impact on performance, safety nor effectiveness of the devices. ณ

#### 7. Non-Clinical Performance data:

As part of demonstrating safety and effectiveness of Flexible Bronchoscope System (= Broncoflex® Agile or Broncoflex® Vortex + Screen®) and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Axess Vision Technology completed a number of non-clinical performance tests. The Flexible Bronchoscope System meets all the requirements for overall design, sterilization, biocompatibility, sterile packaging integrity, shelf life, transportation, electromagnetic compatibility and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The Flexible Bronchoscope System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- . Electrical safety testing per IEC 60601-1:2012 and IEC 60601-2-18:2009
- . Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2:2014 / A1:2020 (Ed. 4.1)
- Software verification and validation testing per IEC 62304:2006/A1 & FDA Guidance

#### 8. Conclusion:

Based on the indications for use, principle of operation, overall technological characteristics and the performance data provided, it is concluded that the functionality and the intended use of the Broncoflex® and Screeni® system is equivalent to the cited predicate devices (= Broncoflex® and Screeni® devices), and is therefore determined to be substantially equivalent.