(77 days)
Not Found
No
The description focuses on the physical characteristics and basic image display/recording functions of the bronchoscope and monitor. There is no mention of any analytical or interpretive capabilities that would suggest AI/ML.
No.
The device is an endoscope designed for visualization and diagnosis within the airways and tracheobronchial tree. While it allows for the use of "endotherapy accessories," the device itself is not described as performing a therapeutic action. Its primary function is diagnostic imaging.
Yes
The "Intended Use / Indications for Use" states that the device is for "endoscopy with the airways and tracheobronchial tree," which implies visualization and inspection of internal body structures. While it also mentions endotherapy accessories, the primary use described is consistent with diagnostic procedures, which often involve visual examination (endoscopy).
No
The device description clearly outlines physical hardware components, including endoscopes with cameras, LED light sources, working channels, and a reusable monitor. This indicates it is a hardware-based medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The aScope 3 system is a flexible bronchoscope used for direct visualization of the airways and tracheobronchial tree within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "endoscopy with the airways and tracheobronchial tree," which is an in-vivo procedure.
- Device Description: The description details a camera, light source, and working channel for visualization and potential accessory use inside the body.
Therefore, the aScope 3 system is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
| Minimum ETT inner diameter | Minimum DLT size | |
|---|---|---|
| aScope 3 Slim 3.8/1.2 | 5.0 mm | 37 Fr |
| aScope 3 Regular 5.0/2.2 | 6.0 mm | 41 Fr |
| aScope 3 Large 5.8/2.8 | 7.0 mm | - |
Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.
Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.
Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The Ambu® aScope™ 3 System consists of: Ambu® aScope™ 3 Regular 5.0/2.2 Ambu® aScope™ 3 Slim 3.8/1.2 Ambu® aScope™ 3 Large 5.8/2.8 Ambu® aView™ Monitor Ambu® aScope™ 3 is a sterile single use flexible bronchoscope and Ambu® aView™ is a reusable monitor.
Ambu® aScope™ 3 endoscopes has 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 the Ambu® aScope™ 3 endoscope sizes 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 on the screen. Can record snapshots or video of image from Ambu® aScope™ 3 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
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™ 3 Large 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 and endurance of the bending section 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Ambu A/S % Mr. Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045
Re: K161656
Trade/Device Name: Ambu Ascope 3 Regular 5.0/2.2, Ambu Ascope 3 Slim 3.8/1.2, Ambu Ascope 3 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: August 5, 2016 Received: August 8, 2016
Dear Mr. 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
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Indications for Use
510(k) Number (if known)
K161656
Device Name
Ambu® aScope™ 3 Regular 5.0/2.2; Ambu® aScope™ 3 Slim 3.8/1.2; Ambu® aScope™ 3 Large 5.8/2.8 Ambu® aView™ Monitor
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
| Minimum ETT inner diameter | Minimum DLT size | |
|---|---|---|
| aScope 3 Slim 3.8/1.2 | 5.0 mm | 37 Fr |
| aScope 3 Regular 5.0/2.2 | 6.0 mm | 41 Fr |
| aScope 3 Large 5.8/2.8 | 7.0 mm | - |
Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.
Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.
Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.
| 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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Section 5 510(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 7225 2000
Fax.: +45 7225 2050 | | | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------|------------------------|
| Contact Person | Name: Camilla Wismar
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2208
Fax number: +45 7225 2050 | | | |
| Date Summary Prepared | June 7, 2016 | | | |
| Device Trade Name | Ambu® aScope™ 3 Regular 5.0/2.2
Ambu® aScope™ 3 Slim 3.8/1.2
Ambu® aScope™ 3 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 | A+B: | Manufacturer
Ambu A/S | Trade Name
Ambu® aScope 3™ 5.0/2.2, Ambu®
aScope™ 3 Slim 3.8/1.2
and Ambu® aView | 510k number
K130845 |
| | C: | Olympus Corporation | Olympus BF-1TH190
Video Bronchoscope | K121959 |
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| Description of the Device | The Ambu® aScope™ 3 System consists of:
Ambu® aScope™ 3 Regular 5.0/2.2 Ambu® aScope™ 3 Slim 3.8/1.2 Ambu® aScope™ 3 Large 5.8/2.8 Ambu® aView™ Monitor Ambu® aScope™ 3 is a sterile single use flexible bronchoscope and Ambu® aView™ is a reusable monitor.
Ambu® aScope™ 3 endoscopes has 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 the Ambu® aScope™ 3 endoscope sizes 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 on the screen. Can record snapshots or video of image from Ambu® aScope™ 3 endoscope. Can connect to an external monitor. Reusable device | | | | | | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Indications for Use | The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes: | | | | | | | | | | | | |
| | Minimum ETT inner diameter Minimum DLT size aScope 3 Slim 3.8/1.2 5.0 mm 37 Fr aScope 3 Regular 5.0/2.2 6.0 mm 41 Fr aScope 3 Large 5.8/2.8 7.0 mm - | | | | | | | | | | | | |
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| Summary of the
technological
characteristics
in comparison
to the predicate
devices | Endoscopic accessories designed for a minimum working channel
width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.
Endoscopic accessories designed for a minimum working channel
width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.
Endoscopic accessories designed for a minimum working channel
width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.
Ambu® aScope™ 3 Regular, Ambu® aScope™ Slim and Ambu®
aView™ are similar to predicate devices described in K130485.
The product line extension Ambu® aScope™ 3 Large 5.8/2.8 is similar
to the predicate devices in the following areas:
They are all flexible endoscopes with a maneuverable tip Predicate A and B has same intended use. Reference C has a similar intended use. Predicate A and B are single-use device, which are delivered sterile. Predicate A and B uses a LED-light source located at the tip of the endoscopes. They are all video endoscopes with a camera located in the distal tip to provide an image on a separate monitor. They all have the same insertion tube working length. They all have suction functionality. Predicate A and B possess a suction port equivalent to aScope 3 Large. The aScope 3 Large inner and outer diameters are equivalent to the reference device: Reference C have the same distal end outer diameter as aScope 3 Large. Predicate A and B have a smaller diameter. Reference C has the same working channel inner diameter as aScope 3 Large. Predicate A and B have a smaller working channel inner diameter |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data -Bench | The following data are described for the product line extension Ambu®
aScope™ 3 Large 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 and endurance of the bending section 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. |
| Conclusion | Based on the indication for use, technological characteristics,
performance data and comparison to predicate devices it has been
concluded that the functionality and intended use of Ambu® aScope™
3 Regular 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aScope™
3 Large 5.8/2.8 and Ambu® aView™ Monitor is equivalent to the
predicate devices.
It is concluded that Ambu® aScope™ 3 Regular 5.0/2.2, Ambu®
aScope™ 3 Slim 3.8/1.2, Ambu® aScope™ 3 Large 5.8/2.8 and
Ambu® aView™ Monitor are as safe and effective and perform as well
as or better than the chosen legally marketed predicate devices. |
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