(159 days)
Not Found
No
The 510(k) summary describes a standard video-bronchoscope system for optical display and use with accessories. There is no mention of AI, ML, image processing for analysis, or any data processing beyond displaying the live image. The performance studies focus on electrical safety, EMC, and software validation for basic functionality, not AI/ML performance metrics.
No
The device is described as a video-bronchoscope intended to provide an optical display of the pulmonary tract and to be used with endotherapy accessories and instruments, which suggests diagnostic and interventional capabilities rather than direct therapeutic function.
Yes
The device, a video-bronchoscope, is intended to provide an optical display of the pulmonary tract, which is used for visualizing and thus diagnosing conditions within the pulmonary tract.
No
The device description clearly states that the system is made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The Broncoflex is a single-use video-bronchoscope with flexible tubing, and the Screeni is a reusable video processor with an integrated touch interface. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an optical display of the pulmonary tract and to be used with endotherapy accessories and instruments. This is a direct visualization and interventional tool, not a device used to examine specimens derived from the human body in vitro to provide information for diagnostic purposes.
- Device Description: The device is a video-bronchoscope system for visualizing the pulmonary tract. It captures live imaging data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples. The device's function is purely observational and interventional within the body.
Therefore, the Broncoflex® Agile and Broncoflex® Vortex system falls under the category of an endoscopic device for direct visualization and intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
endotracheal tube size | Minimum compatible dual
lumen endo-bronchial tube size | Maximum size of
endotherapy instruments |
|-------------------|----------------------------------------------|-----------------------------------------------------------|--------------------------------------------|
| Broncoflex Agile | >= 5.0 mm | >= 35 Fr. | = 6.0 mm | >= 41 Fr. |
§ 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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
endotracheal tube size | Minimum compatible dual
lumen endo-bronchial tube size | Maximum size of
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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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 | |
| 6 rue de la flottière | ||
| 37300 Joué-lès-Tours | ||
| France | ||
| Contact Person: | Marie-Hélène BACHELEY | Regulatory Affairs & Quality Assurance Manager |
| Address: | Zone de la Liodière | |
| 6 rue de la flottière | ||
| 37300 Joué-lès-Tours | ||
| Phone Number: | +33 (0)2 47 34 32 96 | |
| Fax Number: | NA | |
| Date Summary Prepared: | 20 August 2021 |
2. Device:
| Name of Device: | Broncoflex® Agile; Product Reference: 20030001
Broncoflex® Vortex; Product Reference: 10030001
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 |
| Broncoflex® Vortex | |
| 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
endotracheal tube size | Minimum compatible
dual lumen endo-
bronchial tube size | Maximum size of
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
Subject device | Broncoflex® Agile
Subject device | Broncoflex® Vortex
Predicate device | Broncoflex® Agile
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
deflection
angle | 200°/200° | 220°/220° | 200°/200° | 220°/220° |
| External
diameter
of insertion tube | 5.4 mm | 3.6 mm | 5.4 mm | 3.6 mm |
| Distal
end
outer
diameter | 5.6 mm | 3.9 mm | 5.6 mm | 3.9 mm |
| Operator channel inner
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®
Subject device | Screeni®
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
electrocution | Class 2 | Class 2 |
| Battery type | Lithium-Ion battery (11,25V -
2950mAh or 10,8V – 3350mAh) | Lithium-Ion battery (11,25V -
2950mAh or 10,8V – 3350mAh) |
| Battery Operation | At least 3 hours (for a new and fully
charged battery) | At least 3 hours (for a new and fully
charged battery) |
| MECHANICAL CHARACTERISTICS | | |
| Dimensions | L: 300 mm x H: 200 mm x D: 110 mm
(mounting bracket folded) | L: 300 mm x H: 200 mm x D: 110 mm
(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 | ||
| System | IP30 | IP30 |
| Exported file formats | Photos: .JPG | |
| Videos: .AVI (h264 compression) | Photos: .JPG | |
| Videos: .AVI (h264 compression) | ||
| TECHNICAL CHARACTERISTICS | ||
| Internal storage capacity | 16 Gb (can store up to 14 h of video or | |
| more than 100,000 photos) | 16 Gb (can store up to 14 h of video or | |
| 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 | ||
| DVI compatible monitor only and with the | ||
| 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.