(145 days)
No
The 510(k) summary describes a standard endoscopic system for visualization and instrument passage. There is no mention of AI, ML, or any advanced image processing beyond basic display and recording. The performance studies focus on standard device characteristics and safety, not algorithmic performance.
No.
The device is intended for visualization and to allow passing endotherapy instruments, not for directly treating a condition.
Yes
The device is intended for "endoscopic procedures and examination" within the airways, and provides "visualization" to allow for observation and assessment, which are key aspects of diagnosis. While it also allows for therapeutic intervention, its primary function described is to provide diagnostic visual information.
No
The device description clearly outlines hardware components including the endoscope with an integrated camera module and LED illumination, and the aBox 2 displaying unit which is a physical monitor. The system is described as a combination of these hardware elements.
Based on the provided information, the Ambu® aScope™ 5 Broncho HD system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Ambu aScope 5 Broncho HD Function: The Ambu aScope 5 Broncho HD system is used for direct visualization of the airways and tracheobronchial tree within the patient's body (in vivo). It provides live imaging and allows for the passage of instruments for procedures. It does not analyze specimens outside the body.
- Intended Use: The intended use clearly states "for endoscopic procedures and examination within the airways and tracheobronchial tree" and "to provide visualization". This aligns with an in vivo diagnostic and therapeutic device, not an in vitro one.
- Device Description: The description details an endoscope that is inserted into the patient's airway and a display unit for viewing the live images. This is consistent with an in vivo imaging system.
In summary, the Ambu® aScope™ 5 Broncho HD system is an in vivo medical device used for visualization and procedures within the patient's body, not an in vitro diagnostic device that analyzes specimens outside the body.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data -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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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
2
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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3
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/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax: +45 7225 2050 | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Gurpreet Kaur Rehal
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2116
Fax number: +45 7225 2050 | |
| Date Summary
Prepared | March, 01, 2022 | |
| Device Trade
Name | Ambu® aScope™ 5 Broncho HD 5.0/2.2
Ambu® aScope™ 5 Broncho HD 5.6/2.8
Ambu® aBox™ 2 | |
| Device Common
Name | Endoscopy system | |
| Device
Classification | Ambu® aScope™ 5 Broncho HD:
Bronchoscope (flexible or rigid)
and accessories
Product Codes: EOQ
21 CFR 874.4680
Class II | Ambu® aBox™ 2:
Bronchoscope (flexible or rigid)
and accessories
Product Codes: EOQ
21 CFR 876.4680
Class II |
| Legally
Marketed
devices to which
the device is
substantially
equivalent | Predicate Device A:
Ambu® aScope™ 4 Broncho
Regular and Large
K173727
Reference Device B:
OLYMPUS EVIS EXERA III
Bronchovideoscope BF-H190
K121959 | Predicate Device:
OLYMPUS EXERA II Light Source
(CLV-180) and Video System
Center (CV-180)
K061313 |
| Description of
the Device | 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 | |
| Intended
use/Indications
for 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 the
technological
characteristics
in comparison to
the predicate
devices | 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 optical
system, bending section, diameter of insertion cord & distal end and
insertion 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 the
predicate 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 same
technological 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. | |
| Performance
Data -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 | |
4
5
6
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.