(79 days)
Broncoflex Agile and 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.
Screeni: This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex @ video-bronchoscope.
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 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 non-sterile medical device and is a video processor with interface touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex.
The provided text does not contain detailed acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Broncoflex Agile, Broncoflex Vortex, and Screeni) and primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.
Here's an breakdown of the available information and what is missing:
The document states:
- "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"
- "Image quality comparison image quality was assessed same or better compared to predicate devices"
- "Cleaning of display monitor – met performance requirements"
- "Functionality tests (conditions in use) and climatic tests (transport and storage conditions) -. image present and number of deflections up/down specified during 5 defined cycles"
However, it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those specific criteria (beyond general statements like "met performance requirements" or "same or better").
- Details about the study design, such as sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for any image quality comparison.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies, effect sizes with or without AI assistance, or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, expert consensus, outcomes data) for any comparative studies.
- Sample size for training sets or how ground truth for training sets was established, as this device does not appear to employ AI as a primary component.
Therefore, I cannot fully answer your request based solely on the provided text, as much of the requested information is absent.
Based on the provided document, here's what can be extracted, though it's incomplete for your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance Summary (from text) |
|---|---|
| Overall design requirements | Met requirements |
| Sterilization | Met requirements (Ethylene oxide process validated per ISO 11135:2014) |
| Biocompatibility | Passed testing per ISO 10993-1:2018 |
| Sterile packaging integrity | Validated per ISO 11607:2019 and ASTM F 1980:2016 Standards |
| Shelf life | Validated per ISO 11607:2019 and ASTM F 1980:2016 Standards |
| Transportation | Passed testing per ISTA 3A:2018 and ISTA 3E:2017 |
| Electromagnetic Compatibility (EMC) | Passed testing per IEC 60601-1-2:2014 (4th Ed.) |
| Electrical safety | Passed testing per IEC 60601-1:2012 and IEC 60601-2-18:2009 |
| Software verification and validation | Passed testing per IEC 62304:2006/A1 & FDA Guidance |
| Compliance to Endoscope Standards | Compliant to ISO 8600-1:2015, ISO 8600-3:2019 and ISO 8600-4:2014 |
| Photobiological safety | Compliant per IEC 62471:2006 |
| Compatibility with endotherapy accessories | Demonstrated passage of instrument through endoscope and vice-versa |
| Image quality | Assessed same or better compared to predicate devices |
| Cleaning of display monitor | Met performance requirements |
| Functionality (conditions in use) | Image present and specified deflections up/down during 5 cycles |
| Climatic tests (transport and storage) | Met requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document for any specific clinical or comparative performance test. The non-clinical tests (e.g., biocompatibility, electrical safety) would have their own sample sizes, but these are not detailed.
- Data Provenance: Not specified for any comparative or clinical data. The submitter is Axess Vision Technology, located in Joué-lès-Tours, France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "Image quality comparison image quality was assessed same or better compared to predicate devices" but does not detail how this assessment was done, by whom, or with what ground truth.
4. Adjudication method for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not mentioned. This device system (flexible bronchoscope and display monitor) is not described as having an AI component that would necessitate such a study. The focus is on physical and performance characteristics, and equivalence to existing predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not mentioned. Again, an AI algorithm is not a described component of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for any comparative performance claims. For non-clinical tests, the "ground truth" would be the specified requirements and standards.
8. The sample size for the training set:
- Not applicable, as an AI component is not described.
9. How the ground truth for the training set was established:
- Not applicable, as an AI component is not described.
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October 22, 2020
Axess Vision Technology % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K202180
Trade/Device Name: Broncoflex Agile; Product Reference: 20030001, Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: October 5, 2020 Received: October 6, 2020
Dear Dave Yungvirt:
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.
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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 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.
for Malvina Eydelman, M.D. 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) K202180
Device Name
Broncoflex Agile®, Broncoflex Vortex® and Screeni®
Indications for Use (Describe) Broncoflex Agile and 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 compatibleendotracheal tube size | Minimum compatible dual lumenendo-bronchial tube size | Maximum size ofendotherapy instruments |
|---|---|---|---|
| BroncoflexAgile | ≥5.0 mm | ≥35 Fr. | ≤1.2 mm |
| BroncoflexVortex | ≥6.0 mm | ≥41 Fr. | ≤2.6 mm |
Patient Population
The Broncoflex can only be used in 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)
K202180
1. Submitter:
| Submitter's Name:Address: | Axess Vision TechnologyZone de la Liodière6 rue de la flottière37300 Joué-lès-ToursFrance |
|---|---|
| Contact Person: | Marie-Hélène BACHELEYRegulatory Affairs & Quality Assurance ManagerAddress:Zone de la Liodière6 rue de la flottière37300 Joué-lès-Tours |
| Phone Number: | +33 (0)2 47 34 32 90 |
| Fax Number: | NA |
| Date Summary Prepared: | 22 October 2020 |
2. Device:
| Name of Device: | Broncoflex® Agile; Product Reference: 20030001Broncoflex® Vortex; Product Reference: 10030001Screeni®; 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: | Ambu® |
|---|---|
| Trade Name: | aScope™ 4 Broncho Slim 3.8/1.2 |
| aScope™ 4 Broncho Large 5.8/2.8 | |
| aView™ Monitor | |
| 510(K) Number: | K173727 |
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 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 interface 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 and EU/US/UK/AU adaptors). 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 than the Broncoflex Vortex.
5. Indications for Use:
1. Broncoflex Agile and 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 | $\ge 5.0$ 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 | Broncoflex®Agile | aScope™ 4Broncho Slim | aScope™ 4Broncho Large |
|---|---|---|---|---|
| Product reference | 10030001 | 20030001 | 476001000 | 478001000 |
| Field of vision direction | 0° | 0° | 0° | 0° |
| Field angle | 87,5° | 87,5° | 85° | 85° |
| Field depth | 5 - 50 mm | 5 - 50 mm | 6 - 50 mm | 6 - 50 mm |
| High/low deflectionangle | 200°/200° | 220°/220° | 180°/180° | 180°/160° |
| External diameterof insertion tube | 5.4 mm | 3.6 mm | 5.8 mm | 5.8 mm |
| Distal end outerdiameter | 5.6 mm | 3.9 mm | 4.2 mm | 6.2 mm |
| Operator channel innerdiameter | 2.8 mm | 1.4 mm | 1.2 mm | 2.6 mm |
| Working length | 605 mm | 605 mm | 600 mm | 600 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
The Broncoflex Vortex and Broncoflex Agile are similar to the predicate devices in the following areas:
- Field of vision direction .
- . Lighting system (2 LEDs)
- . Image resolution
- Sterile with ETO .
2. Screeni
Screeni is technologically substantially equivalent to the predicate device.
| Table 2: Screeni and aViewTechnical Characteristics |
|---|
| ----------------------------------------------------- |
| Type | Screeni® | aView™ Monitor |
|---|---|---|
| Product reference | 30030001 | 405001000 (vers.v1) |
| 405002000 (vers.v2) | ||
| 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 |
| Battery type | Lithium-Ion battery (11,25V -2950mAh) | Lithium-Ion battery (10,8V - 4300mAh) |
| Battery Operation | At least 3 hours (for a new and fullycharged battery) | Typical battery runtime of a new, fullycharged battery(aView turned on and scope connected)is min. 3 hours) |
| MECHANICAL CHARACTERISTICS | ||
| Dimensions | L: 300 mm x H: 200 mm x D: 110 mm(mounting bracket folded) | Width: 241 mm Height : 175mmThickness: 33.5 mm |
| Weight | 1.8 kg (with mounting bracket) | 1,5 kg |
| Mounting interface | VESA 75 mm | VESA MIS-D, 75 C, VESA FDMI |
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| compliant display, Part D, withcentre located mounting interface | ||
|---|---|---|
| TOUCH SCREEN | ||
| Resolution | 1280x800 | 800x480 |
| Display type | 10.1-inch TFT LCD | 8.5" colour TFT LCD |
| MISCELLANEOUS CHARACTERISTICS | ||
| IP ProtectionSystem | IP30 | IP30 |
| Format | Photos: JPGVideos: AVI (h264 compression) | Not specified |
| TECHNICAL CHARACTERISTICS | ||
| Storage capacity | 16 Gb (can store up to 14 h of videoor more than 100,000 photos) | 8GB |
| USB connection | Type A (for USB key connectiononly) | Type A |
| Power out (electrical power) | DC 15V / 2A input | 18V DC / 1.67A |
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 .
The Screeni is similar than the predicate device in the following areas:
- Touch screen .
- Battery time/operation (3 hours) .
- Battery type (Lithium-ion) .
- Storage capacity .
- USB connection ●
7. Non-Clinical Performance data:
As part of demonstrating safety and effectiveness of Flexible Bronchoscope System (= Broncoflex® Agile or Broncoflex® Vortex + Screeni®) 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:
- . Biocompatibility testing per ISO 10993-1:2018
- . Electrical safety testing per IEC 60601-1:2012 and IEC 60601-2-18:2009
- Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2:2014 (4th Ed.) .
- Software verification and validation testing per IEC 62304:2006/A1 & FDA Guidance .
- Compliance to ISO 8600-1:2015, ISO 8600-3:2019 and ISO 8600-4:2014 testing .
- . Sterilization Process validation per ISO 11135:2014
- . Sterile packaging integrity validation and Shelf life validation per ISO 11607:2019 and ASTM F 1980:2016 Standards
- . Transportation testing per ISTA 3A:2018 and ISTA 3E:2017
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- Photobiological safety per IEC 62471:2006
- Compatibility with endotherapy accessories and instruments passage of the instrument through endoscope is demonstrated and passage of the endoscope through the accessory is demonstrated
- Image quality comparison image quality was assessed same or better compared to predicate devices
- . Cleaning of display monitor – met performance requirements
- Functionality tests (conditions in use) and climatic tests (transport and storage conditions) -. image present and number of deflections up/down specified during 5 defined cycles
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, and is therefore determined to be substantially equivalent.
§ 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.