(217 days)
No
The summary describes a standard bronchoscope system for visualization and instrument passage, with no mention of AI, ML, or advanced image processing beyond basic display and recording.
No
The device is primarily intended for visualization and allows the passing of endotherapy instruments, but it does not directly perform therapy itself.
Yes
The device is described as being for "endoscopic procedures and examination," and its function involves "visualization" and "displaying live imaging data," which are common elements of diagnostic tools used to observe internal body structures for medical assessment.
No
The device is described as a system combining a displaying unit (hardware) and an endoscope (hardware with integrated camera and working channel). The performance studies include testing of physical characteristics, electrical safety, and biocompatibility, all indicative of a hardware device.
Based on the provided information, the Ambu® aScope™ 5 Broncho HD system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic procedures and examination within the airways and tracheobronchial tree" and to "provide visualization" and "allow passing endotherapy instruments." This describes a device used for direct visualization and intervention within the body, not for testing samples taken from the body.
- Device Description: The description details a bronchoscope with a camera and a display unit. It describes the physical insertion into the patient's airway and the ability to use instruments through a working channel. This aligns with an in-vivo diagnostic or therapeutic device, not an in-vitro one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. The device's function is to provide visual information and access for procedures within the patient.
In summary, the Ambu® aScope™ 5 Broncho HD system is a medical device used for direct visualization and intervention within the patient's airways, which falls under the category of an in-vivo device, not an in-vitro diagnostic device.
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 Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
Product codes
EOQ
Device Description
The Ambu® aScope™ 5 Broncho HD system is a combination of the displaying unit, Ambu® aView™ 2 Advance, 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 bronchoscopes are the same devices as cleared in K220606. The only change is that the bronchoscopes are now also compatible to Ambu® aView™ 2 Advance.
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® aView™ 2 Advance, 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 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.
Ambu® aView™ 2 Advance 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
Not Found
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
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- and comparison 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
- Image Intensity Uniformity
- Geometrical Distortion
- Resolution
- Color Performance
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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1, 2023
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045
Re: K223299
Trade/Device Name: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: April 27, 2023 Received: May 1, 2023
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 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.
Joyce C. Lin -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K223299
Device Name Ambu® aScope™ 5 Broncho HD 5.0/2.2 Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aView™ 2 Advance
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 Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
3
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) summary 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: Magnus Lynge
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2165 | |
| Date Summary
Prepared | April 26th, 2023 | |
| Device Trade
Name | Ambu® aScope™ 5 Broncho HD 5.0/2.2
Ambu® aScope™ 5 Broncho HD 5.6/2.8
Ambu® aView™ 2 Advance | |
| 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® aView™ 2 Advance:
Bronchoscope (flexible or rigid) and accessories
Product Codes: EOQ
21 CFR 874.4680
Class II |
| Legally Marketed
devices to which
the device is
substantially
equivalent | Predicate Device:
Ambu® aScope™ 5 Broncho HD 5.0/2.2
Ambu® aScope™ 5 Broncho HD 5.6/2.8
K220606 | Predicate Device:
Ambu® aBox™ 2
K220606
Reference Device:
Ambu® aView™
K173727 |
| Description of the
Device | The Ambu® aScope™ 5 Broncho HD system is a combination of the
displaying unit, Ambu® aView™ 2 Advance, 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
bronchoscopes are the same devices as cleared in K220606. The only
change is that the bronchoscopes are now also compatible to
Ambu® aView™ 2 Advance. | |
| | 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® aView™ 2 Advance, 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 12.8" LCD
screen. The device is powered through a Lithium-ion (Li-ion) battery
or a separate power adapter. | |
| | Ambu® aView™ 2 Advance 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 Ambu® aView™ 2 Advance is intended to display live imaging data
from compatible Ambu visualization devices. | |
4
5
| Summary of the technological characteristics in comparison to the predicate devices |
|---|
| The Ambu® aScope™ 5 Broncho HD and its predicate device, are identical devices. The only difference is, that now the devices are also compatible with the Ambu® aView™ 2 Advance displaying unit. |
| The subject device Ambu® aView™ 2 Advance and its predicate device, the Ambu® aBox™ 2, have the following same technological characteristics: |
| Both are 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 such as brightness control, image contrast adjustment, live image sharpness adjustment and zoom function. Both have a built-in LCD screen that provides live imaging data from the connected supported visualization device. The LCD screens are identical. |
| The differences between the Ambu® aView™ 2 Advance and the predicate device are as follows: |
| Ambu® aView™ 2 Advance can be hung on an IV pole by means of a bracket. Ambu® aView™ 2 Advance has both 3G-SDI and HDMI video outputs to allow connection with external medical monitors, whereas the predicate device offers the video output through 3G-SDI and DVI. Ambu® aView™ 2 can be powered through a Lithium-ion (Li-ion) battery. |
| 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. |
6
Performance- and comparison 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
- Image Intensity Uniformity
- Geometrical Distortion .
- . Resolution
- Color Performance .
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.
7
Conclusion The Ambu® aScope™ 5 Broncho HD system, consisting of Ambu® aScope™ 5 Broncho HD and Ambu® aView™ 2 Advance, 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 rnerelory it is concluded that Annual " assope" - 5 Brondho HD System"
E Provincial UD F 6 0 0 - 1 1 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8 and Ambu® aView™ 2 Advance is substantial equivalent to its predicate devices.