(50 days)
Not Found
No
The summary describes a standard bronchoscope and display unit with basic imaging and recording capabilities. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies. The performance studies focus on electrical safety, EMC, and optical performance, not AI/ML model validation.
No
The device is intended for endoscopic procedures and examination within the airways, providing visualization and allowing passing of endotherapy instruments. It is explicitly described as a bronchoscope for diagnostic visualization, with no mention of active treatment or therapy as its primary function. While it allows for the passage of endotherapy instruments, it itself is not a therapeutic device.
Yes
The device is intended for "endoscopic procedures and examination within the airways and tracheobronchial tree" and to "provide visualization". These functions are often part of the diagnostic process to observe and identify medical conditions within the specified anatomical sites.
No
The device description clearly states that the system is a combination of a physical endoscope (Ambu® aScope™ 5 Broncho) and a physical displaying unit (Ambu® aView™ 2 Advance). The endoscope has hardware components like a camera module, LED illumination, and a working channel. The displaying unit is a physical monitor. Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic procedures and examination within the airways and tracheobronchial tree" and to "provide visualization" and "allow passing of endotherapy instruments." This describes a device used for direct visualization and intervention within the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a flexible bronchoscope with a camera and a display unit. This is consistent with an endoscopic system used for direct examination of the respiratory tract.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition. The device is used for visual inspection and procedural access.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on direct visualization and access within the patient's airways.
N/A
Intended Use / Indications for Use
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of 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 (comma separated list FDA assigned to the subject device)
EOO, EOQ
Device Description
The Ambu® aScope™ 5 Broncho System is a combination of an endoscope, Ambu® a5cope™ 5 Broncho, and a compatible displaying unit, Ambu® aView™ 2 Advance.
Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.
The Ambu® aView™ 2 Advance, also referred to as a 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 the Ambu® aScope™ 5 Broncho endoscope on the screen.
- · Can record snapshots or video of image from Ambu® aScope™ 5 Broncho 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety according to IEC 60601-1 and IEC 60601-2-18
Electromagnetic Compatibility according to IEC 60601-1-2
Optical performance tests:
o Depth of field
o Resolution
o Geometric distortion
o Image intensity uniformity
o Color performance
Overall, the Ambu® aScope™ 5 Broncho 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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2024
Ambu A/S % Sanjay Parikh Senior Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive Suite 200 Columbia, Maryland 21046
Re: K233671
Trade/Device Name: Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: November 15, 2023 Received: December 5, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Shuchen Peng -S
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
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Indications for Use
Submission Number (if known)
Device Name
Ambu® aScope™ 5 Broncho 4.2/2.2;
Ambu® aScope™ 5 Broncho 2.7/1.2:
Ambu® aView™ 2 Advance
Indications for Use (Describe)
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of 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)
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510(k) Summary
Prepared on: 2023-11-15
Contact Details
| Applicant Name | Ambu A/S |
|---|---|
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark |
| Applicant Contact Telephone | +45 7225 2508 |
| Applicant Contact | Mr. Lasse Sohrt-Petersen |
| Applicant Contact Email | lass@ambu.com |
| Correspondent Name | Ambu Inc. |
| Correspondent Address | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046 |
| United States | |
| Correspondent Contact Telephone | +1 443 367 4502 |
| Correspondent Contact | Mr. Sanjay Parikh |
| Correspondent Contact Email | sap@ambu.com |
| Device Name | |
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | Ambu® aScope™ 5 Broncho 4.2/2.2; |
| Ambu® aScope™ 5 Broncho 2.7/1.2; | |
| Ambu® aView™ 2 Advance | |
| Common Name | Bronchoscope (flexible or rigid) and accessories |
| Classification Name | Bronchoscope (Flexible Or Rigid) |
| Regulation Number | 874.4680 |
| Product Code | EOQ |
| Legally Marketed Predicate Devices | |
| 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| Product Code | |
| K230428 | Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aScope™ 5 Bronch EOQ |
| K223299 | Ambu® aView™ 2 Advance EOQ |
| Device Description Summary | |
| 21 CFR 807.92(a)(4) |
The Ambu® aScope™ 5 Broncho System is a combination of an endoscope, Ambu® a5cope™ 5 Broncho, and a compatible displaying unit, Ambu® aView™ 2 Advance.
Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and
4
Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.
The Ambu® aView™ 2 Advance, also referred to as a 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 the Ambu® aScope™ 5 Broncho endoscope on the screen.
- · Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope.
- · Can connect to an external monitor.
- · Reusable device.
Intended Use/Indications for Use
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.
The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
Indications for Use Comparison
The intended use / indications for use are the same as for the predicate devices.
Technological Comparison
Ambu® aScope™ 5 Broncho is identical to its predicate device (Ambu® aScope™ 5 Broncho submitted in K230428); the only difference is that the subject device is compatible with an additional displaying unit, Ambu® aView™ 2 Advance.
Ambu® aView™ 2 Advance was cleared for use with Ambu° aScope™ 5 Broncho HD in K223299. Equivalent to the bronchoscope subject to this 510(k), the main difference between the subject aView 2 Advance is the additional compatibility to Ambuy aScope™ 5 Broncho. There have been no significant characteristics of the device since the submission of K223299.
The differences do not raise any new questions of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
In addition to the performance testing described in the original 510(k)s (K223299 and K230428), additional testing has been performed to address the risks associated with the additional compatibility and to support substantial equivalence to the predicate devices:
· Electrical Safety according to IEC 60601-1 and IEC 60601-2-18
- · Electromagnetic Compatibility according to IEC 60601-1-2
- · Optical performance tests:
- o Depth of field
- o Resolution
- o Geometric distortion
- o Image intensity uniformity
- o Color performance
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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Overall, the Ambu® aScope™ 5 Broncho System performed as expected and met the test specifications set.
In conclusion, Ambu® aScope™ 5 Broncho and Ambu® aView™ 2 Advance constituting the Ambu® aScope™ 5 Broncho System, have the same intended use/indications for use and similar technological characteristics as the predicate devices.
The minor technological differences between Ambu® aView™ 2 Advance and their respective predicate device do not raise any different questions regarding safety or effectiveness and have been addressed in the performance testing listed above.
Therefore, it is concluded that the devices in the subject Ambu® aScope™ 5 substantially equivalent to the legally marketed predicates.