(145 days)
Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing endotherapy instruments via its working channel.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu aScope 5 Broncho HD System is a combination of the displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho HD 5.6/2.8.
The Ambu aScope 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.
Ambu aScope 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.
The Ambu aBox 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
Ambu® aBox 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device.
This document describes a 510(k) premarket notification for the Ambu aScope 5 Broncho HD system. The acceptance criteria and the study proving the device meets these criteria are primarily based on bench testing and adherence to international standards for endoscopes, rather than a clinical study evaluating AI performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance requirements evaluated in accordance with the ISO 8600 series: | All tests passed. |
| - ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements | Met standard requirements. |
| - ISO 8600-3:2019 Optics and optical instruments - Medical endoscopes and certain accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics | Met standard for field of view and direction of view. |
| - ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Determination of maximum width of insertion portion | Met standard for insertion portion width. |
| - ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics | Met standard for optical resolution. |
| - ISO 8600-6:2020 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary | Met standard for vocabulary. |
| Performance test reports to document the following properties: | All tests passed. |
| - Field of view | Met specifications. |
| - Direction of view | Met specifications. |
| - Depth of Field | Met specifications. |
| - Insertion cord dimensions | Met specifications. |
| - Suction performance | Met specifications. |
| - Bending performance | Met specifications. |
| - Duration of use | Met specifications. |
| Performance test reports to document shelf life. Tests were performed on finished, sterilized, and aged products: | All tests passed. |
| - Performance tests | Met specifications after aging. |
| - Sterile packaging integrity | Maintained integrity after aging. |
| Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization, and systemic toxicity: | All tests passed. |
| - Cytotoxicity (ISO 10993-5) | Met standard. |
| - Irritation (ISO 10993-23) | Met standard. |
| - Sensitization (ISO 10993-10) | Met standard. |
| - Systemic toxicity test (ISO 10993-11) | Met standard. |
| Test reports that verify the Electromagnetic Compatibility and Electrical Safety: | All tests passed. |
| - Electromagnetic Compatibility in compliance with IEC 60601-1-2 | Met standard. |
| - Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18 | Met standard. |
| Overall conclusion: The Ambu® aScope™ 5 Broncho HD system performed as expected and met the test specifications set. | The device system met all test specifications and performed as expected. |
2. Sample size used for the test set and the data provenance
The document describes bench testing and adherence to international standards for device performance, biocompatibility, electromagnetic compatibility, and electrical safety. It does not refer to a "test set" in the context of a clinical study with patient data (e.g., images). Therefore:
- Sample size for the test set: Not applicable in the context of clinical data. The "samples" would be the devices and materials tested according to the listed standards. The exact number of devices or material samples used for each bench test is not specified.
- Data provenance: Not applicable in the context of clinical data. The data is generated from laboratory bench tests and material analyses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the provided document focuses on bench testing and engineering performance evaluations, not diagnostic accuracy studies involving expert interpretation of medical images or data. Ground truth for these types of tests is generally based on objective measurements by calibrated instruments and adherence to established engineering standards.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. The testing described here involves objective pass/fail criteria based on physical and electrical properties, and compliance with standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance was not done or reported in this submission summary. The device described (a bronchoscope and display unit) is a visualization and instrument delivery system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a medical device hardware system, not an AI algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on objective measurements against established engineering and safety standards (e.g., ISO 8600 series, IEC 60601 series, ISO 10993 series parameters for field of view, suction performance, electrical safety, biocompatibility limits, etc.). It is not derived from expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic ground truth.
8. The sample size for the training set
Not applicable. This submission is for a medical device (bronchoscope system), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in this context.
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July 25, 2022
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045
Re: K220606
Trade/Device Name: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2. Ambu aBox 2 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 21, 2022 Received: June 22, 2022
Dear Sanjay Parikh:
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 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) K220606
Device Name Ambu® aScope™ 5 Broncho HD 5.0/2.2 Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aBox™ 2
Indications for Use (Describe)
Ambu@ aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu@ aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing endotherapy instruments via its working channel.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K220606 510(k) Summary
This traditional 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summery has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax: +45 7225 2050 | |
|---|---|---|
| Contact Person | Name: Gurpreet Kaur RehalJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2116Fax number: +45 7225 2050 | |
| Date SummaryPrepared | March, 01, 2022 | |
| Device TradeName | Ambu® aScope™ 5 Broncho HD 5.0/2.2Ambu® aScope™ 5 Broncho HD 5.6/2.8Ambu® aBox™ 2 | |
| Device CommonName | Endoscopy system | |
| DeviceClassification | Ambu® aScope™ 5 Broncho HD:Bronchoscope (flexible or rigid)and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II | Ambu® aBox™ 2:Bronchoscope (flexible or rigid)and accessoriesProduct Codes: EOQ21 CFR 876.4680Class II |
| LegallyMarketeddevices to whichthe device issubstantiallyequivalent | Predicate Device A:Ambu® aScope™ 4 BronchoRegular and LargeK173727Reference Device B:OLYMPUS EVIS EXERA IIIBronchovideoscope BF-H190K121959 | Predicate Device:OLYMPUS EXERA II Light Source(CLV-180) and Video SystemCenter (CV-180)K061313 |
| Description ofthe Device | The Ambu aScope 5 Broncho HD System is a combination of thedisplaying unit, Ambu aBox 2, and a compatible Ambu endoscope, theAmbu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 BronchoHD 5.6/2.8The Ambu aScope 5 Broncho HD endoscopes are single-useendoscopes designed to be used with Ambu displaying units,endotherapy instruments and other ancillary equipment for endoscopywithin the airways and tracheobronchial tree.The insertion portion is inserted into the patient airway through themouth, nose, or a tracheostomy. It is lubricated with a water-solublemedical grade lubricant to ensure the lowest possible friction wheninserted into the patient. There is a working channel system within theendoscope for use with endotherapy instruments. An introducer (luerlock adaptor), which is supplied together with the endoscope, can beattached to the working channel port during use. Suctioning of blood,saliva, and mucus from the airway is possible through the suctionsystem.Ambu aScope 5 Bronco HD features an integrated camera module,with built-in dual LED illumination. The image module provides acropped 800x800 Pixels signal from the 1280x800 (1 megapixel)sensor.The Ambu aBox 2, also referred to as displaying unit, is a non-steriledigital monitor intended to display live imaging data from Ambuvisualization devices. The product consists of a base unit with a 12.8"LCD screen mounted on the top. The device is powered by anintegrated power supply and comes with country specific powercables.Ambu® aBox 2 displaying unit has the following physical andperformance characteristics:Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device | |
| Intendeduse/Indicationsfor use | Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing endotherapy instruments via its working channel.The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices. | |
| Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices | The Ambu® aScope™ 5 Broncho HD and the predicate device, Ambu®aScope™ 4 Broncho are single-use devices.Both devices share similar technological characteristics such as opticalsystem, bending section, diameter of insertion cord & distal end andinsertion portion length.Furthermore, they have the following same technical characteristics: | |
| Both have maneuverable tip controlled by the user Both have flexible insertion cord Both have camera and LED light source at the distal tip Both are sterilized by Ethylene Oxide Both are single use devices Both devices enable aspiration and sample collection in BAL and BW procedures | ||
| The differences between the Ambu® aScope™ 5 Broncho HD and thepredicate device are as follows: | ||
| Ambu® aScope™ 5 Broncho HD has a rotary function as the reference device Ambu® aScope™ 5 Broncho HD has two endoscope buttons as the reference device | ||
| The Ambu® aBox™ 2 and its predicate device have the following sametechnological characteristics: | ||
| Both are video processors displaying live video-imaging data of the connected visualization device to a monitor. Both provide video output formats, recording and data storage and data transport functions. Both share certain technical functionalities as brightness control, image contrast and sharpness adjustment and zoom function. Contrary to the predicate device, the Ambu® aBox™ 2 is portable and has an integrated monitor, therefore, an external monitor is not necessary. | ||
| PerformanceData -Bench | The following tests to verify the design and evaluate the performance of the Ambu® aScope™ 5 Broncho HD system were done. | |
| Performance requirements evaluated in accordance with the ISO 8600 series. ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements ISO 8600-3:2019 Optics and optical instruments - Medical endoscopes and certain accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Determination of maximum width of insertion portion ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics ISO 8600-6:2020 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
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Result: All tests passed.
Performance test reports to document the following properties:
- Field of view ●
- . Direction of view
- Depth of Field ●
- Insertion cord dimensions
- Suction performance .
- . Bending performance
- . Duration of use
Result: All tests passed.
- Performance test reports to document shelf life. Tests were performed on finished, sterilized, and aged products: . Performance tests . Sterile packaging integrity Result: All tests passed. Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization, and systemic toxicity: Cytotoxicity (ISO 10993-5) . Irritation (ISO 10993-23) . Sensitization (ISO 10993-10) ● Systemic toxicity test (ISO 10993-11) . Result: All tests passed. Test reports that verify the Electromagnetic Compatibility and Electrical Safety: ● Electromagnetic Compatibility in compliance with IEC 60601-1-2 Electrical Safety in compliance with IEC 60601-1 and IEC ● 60601-2-18 Result: All tests passed. In all instances, the Ambu® aScope™ 5 Broncho HD system performed as expected and met the test specifications set. Conclusion The Ambu® aScope™ 5 Broncho HD system, consisting of Ambu® aScope™ 5 Broncho HD and Ambu® aBox™ 2, has the same intended use and indications for use, and similar technological characteristics and principles of operation as their predicate devices. The minor technological differences between the Ambu® aScope™ 5 Broncho HD system and its predicate devices raise no new concerns regarding safety or effectiveness. Therefore, it is concluded that Ambu® aScope™ 5 Broncho HD system consisting of Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8 and Ambu® aBox™ 2 is substantial equivalent to its predicate devices.
§ 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.