(113 days)
No
The summary describes a standard bronchoscope system with a monitor for displaying and recording images. There is no mention of any AI or ML capabilities for image analysis, diagnosis, or other functions.
No.
The device is described as an endoscope used for visualization and diagnosis within the airways and tracheobronchial tree ("for endoscopy within the airways and tracheobronchial tree"), and it facilitates the use of endotherapy accessories, but its primary function as described is diagnostic imaging rather than direct therapeutic intervention.
Yes
Explanation: The device is an endoscope designed for visualizing inside airways and the tracheobronchial tree. This visualization primarily serves a diagnostic purpose, allowing clinicians to observe and assess the internal structures for abnormalities or to guide procedures. While it can be used with endotherapy accessories (suggesting therapeutic capabilities), its fundamental role in providing visual information for assessment makes it a diagnostic device.
No
The device description explicitly includes hardware components such as endoscopes with cameras, light sources, working channels, and a reusable monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for endoscopy within the airways and tracheobronchial tree. This is a procedure performed directly on the patient's body for visualization and potentially intervention (using accessories through the working channel).
- Device Description: The device is described as a flexible bronchoscope with a camera and light source at the tip, used to visualize the anatomical site. This is consistent with an endoscopic device used for direct examination of internal body structures.
- Lack of In Vitro Activity: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any tests on specimens outside of the body.
The device is a medical device used for direct visualization and potentially therapeutic procedures within the respiratory system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The aScope 3 and aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The aScope 3 system and aScope 4 Broncho system are for use in a hospital environment.
The aScope 3 and aScope 4 Broncho are single-use designed for use in adults. They have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
aScope 3 Slim and aScope 4 Broncho Slim: Minimum ETT inner diameter 5.0 mm, Minimum DLT size 35 Fr, EA minimum working channel width Up to 1.2 mm
aScope 3 Regular aScope 4 Broncho Regular: Minimum ETT inner diameter 6.0 mm, Minimum DLT size 41 Fr, EA minimum working channel width Up to 2.0 mm
aScope 3 Large aScope 4 Broncho Large: Minimum ETT inner diameter 7.0 mm, Minimum DLT size -, EA minimum working channel width Up to 2.6 mm
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The Ambu® aScope™ 3 system consists of:
Ambu® aScope™ 3 Slim 3.8/1.2
Ambu® aScope™ 3 Regular 5.0/2.2
Ambu® aScope™ 3 Large 5.8/2.8
Ambu® aView™ Monitor
The Ambu® aScope™ 4 Broncho System:
Ambu® aScope™ 4 Broncho Slim 3.8/1.2
Ambu® aScope™ 4 Broncho Regular 5.0/2.2
Ambu® aScope™ 4 Broncho Large 5.8/2.8
Ambu® aView™ Monitor
Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho is a sterile single use flexible bronchoscope and Ambu Ambu® aView™ is a reusable monitor. Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscopes have the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Working channel
Sterilized by Ethylene Oxide
For single use
The differences between sizes in both the Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope are as follows:
Distal end outer diameter
Insertion tube outer diameter
Working channel inner diameter
Angulation range
Ambu® aView™ Monitor has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope on the screen
Can record snapshots or video of image from Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscope
Can connect to an external monitor
Reusable device
The aScope 3 and aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscopes
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment
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 data are described for the product line extension Ambu® aScope™ 4 Broncho System in the premarket notification:
Declaration of Conformity with the product specific standards ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 594-1
Performance tests to document the properties of bending angle, endurance and radius of the bending section, the depth of field and clearer image quality design validation test
Aging Performance Test
Sterile Packaging Integrity Test
Electrical Compatibility according to IEC 60601-1-2
Electrical Safety according to IEC 60601-1 and IEC 60601-2-18
Results: All tests were passed.
Performance Data – Clinical: Not applicable.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2018
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu, Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045
Re: K173727
Trade/Device Name: Ambu® aScope™ 3 Slim 3.8/1.2 and Ambu® aScope™ 4 Broncho Slim 3.8/1.2; Ambu® aScope™ 3 Regular 5.0/2.2 and Ambu® aScope™ 4 Broncho Regular 5.0/2.2; Ambu® aScope™ 3 Large 5.8/2.8 and Ambu® aScope™ 4 Broncho Large 5.8/2.8; Ambu® aView Monitor Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 23, 2018 Received: February 26, 2018
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173727
Device Name
Ambu® aScope™ 3; Ambu® aScope™ 4 Broncho; Ambu® aView™ Monitor
Indications for Use (Describe)
The aScope 3 and aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The aScope 3 system and aScope 4 Broncho system are for use in a hospital environment.
The aScope 3 and aScope 4 Broncho are single-use designed for use in adults. They have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
| | Minimum ETT
inner diameter | Minimum
DLT size | EA minimum working
channel width |
|----------------------------------------------|-------------------------------|---------------------|-------------------------------------|
| aScope 3 Slim and
aScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 Regular
aScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 Large
aScope 4 Broncho Large | 7.0 mm | - | Up to 2.6 mm |
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
510(k) Summary
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the 510(k) has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 72 25 20 00
Fax.: +45 72 25 20 50 | | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Contact Person | Name: Maja Brøns
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 72 25 22 16
Fax number: +45 72 25 20 50 | | | | | | | | | | | | |
| Date Summary
Prepared | December 4, 2017 | | | | | | | | | | | | |
| Device Trade
Name | Ambu® aScope™ 3 Slim 3.8/1.2
Ambu® aScope™ 3 Regular 5.0/2.2
Ambu® aScope™ 3 Large 5.8/2.8
Ambu® aScope™ 4 Broncho Slim 3.8/1.2
Ambu® aScope™ 4 Broncho Regular 5.0/2.2
Ambu® aScope™ 4 Broncho Large 5.8/2.8
Ambu® aView™ Monitor | | | | | | | | | | | | |
| Device Common
Name | Flexible Bronchoscope | | | | | | | | | | | | |
| Device
Classification | 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 Manufacturer Trade Name 510k number A+B+C Ambu A/S Ambu® aScope™ 3 K161656 Reference D Vision-Science BRS-5000 Video
Bronchoscope K091768 | | | | | | | | | | | | |
4
The Ambu® aScope™ 3 system consists of: Description of the Device Ambu® aScope™ 3 Slim 3.8/1.2 . Ambu® aScope™ 3 Regular 5.0/2.2 ● Ambu® aScope™ 3 Large 5.8/2.8 ● Ambu® aView™ Monitor . The Ambu® aScope™ 4 Broncho System Ambu® aScope™ 4 Broncho Slim 3.8/1.2 . Ambu® aScope™ 4 Broncho Regular 5.0/2.2 ● Ambu® aScope™ 4 Broncho Large 5.8/2.8 . Ambu® aView™ Monitor ● Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho is a sterile single use flexible bronchoscope and Ambu Ambu® aView™ is a reusable monitor. Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscopes have the following physical and performance characteristics: . Maneuverable tip controlled by the user Flexible insertion cord ● Camera and LED light source at the distal tip ● Working channel ● . Sterilized by Ethylene Oxide . For single use The differences between sizes in both the Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope are as follows: Distal end outer diameter . ● Insertion tube outer diameter ● Working channel inner diameter ● Anqulation range Ambu® aView™ Monitor has the following physical and performance characteristics: ● Displays the image from Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope on the screen . Can record snapshots or video of image from Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscope . Can connect to an external monitor . Reusable device The aScope 3 and aScope 4 Broncho endoscopes have been Indications for designed to be used with the aView monitor, endotherapy Use accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
5
Special 510(K) Application Ambu aScope 3 System & aScope 4 Broncho System
The aScope 3 system and aScope 4 Broncho system is for use in a hospital environment.
The aScope 3 system and aScope 4 Broncho system are for use in a hospital environment. The aScope 3 and aScope 4 Broncho are single-use devices designed for use in adults.
hey have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
| | Minimum ETT
inner
diameter | Minimum
DLT size | EA
minimum
working
channel
width |
|----------------------------------------------|----------------------------------|---------------------|----------------------------------------------|
| aScope 3 Slim and
aScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 Regular
aScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 Large
aScope 4 Broncho Large | 7.0 mm | - | Up to 2.6 mm |
Summary of the technological characteristics in comparison to the predicate and referenc devices
Ambu® aScope™ 4 is similar to the predicate and reference devices described in K161656 and K091768.
The product line extension Ambu® aScope™ 4 Broncho are similar to the predicate and reference devices in the following areas:
| and reference
| devices | They all have the same intended use They are all single-use devices delivered sterile They are all flexible endoscopes with a maneuverable tip They are all video endoscopes with a camera located in the distal tip to provide an image on a separate monitor They all use an LED-light source located in the distal tip They all have suction functionality They all have a working channel for insertion of endoscopic accessories They all have the same insertion tube working length They all have equivalent inner and outer diameters in their corresponding sizes. |
|---|---|
| Performance | |
| Data -Bench | The following data are described for the product line extension |
| Ambu® aScope™ 4 Broncho System in the premarket notification: Declaration of Conformity with the product specific standards ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 594-1 Performance tests to document the properties of bending angle, endurance and radius of the bending section, the depth of field and clearer image quality design validation test Aging Performance Test Sterile Packaging Integrity Test Electrical Compatibility according to IEC 60601-1-2 Electrical Safety according to IEC 60601-1 and IEC 60601-2-18 |
Results: All tests were passed.
6
| Performance
| Data – Clinical | Not applicable. |
|---|---|
| Conclusion | Based on the indication for use, technological characteristics, |
| performance data and comparison to predicate and reference | |
| devices it is concluded that the functionality and intended use of | |
| Ambu® aScope™ 3, Ambu® aScope™ 4 Broncho and Ambu® aView™ | |
| Monitor is equivalent to the predicate and reference devices. |
It is concluded that Ambu® aScope™ 3, Ambu® aScope™ 4 Broncho
and Ambu® aView™ Monitor are as safe and effective and perform as
well as or better (regarding distal bending section/angulation range,
depth of field and exposure for clearer visibility of the image) than
the chosen legally marketed predicate and reference devices. |