(113 days)
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 ETTinner diameter | MinimumDLT size | EA minimum workingchannel width | |
|---|---|---|---|
| aScope 3 Slim andaScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 RegularaScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 LargeaScope 4 Broncho Large | 7.0 mm | - | Up to 2.6 mm |
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 consists of: 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 provided text is a 510(k) summary for the Ambu® aScope™ 3, Ambu® aScope™ 4 Broncho, and Ambu® aView™ Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed devices, it is not a study that proves a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets them (as would be relevant for an AI/ML device) is not present in the provided text. The document refers to the physical and performance characteristics of flexible bronchoscopes and a monitor, and demonstrates their equivalence to predicate devices based on bench performance tests.
Here's a breakdown of what is available concerning performance and equivalence, and an explanation of why the requested AI/ML specific information is absent:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)
The document outlines the characteristics of the Ambu® aScope™ 3 and 4 Broncho endoscopes and the Ambu® aView™ Monitor, and states that these were evaluated against various standards and performance tests to demonstrate substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit/Standard-based) | Reported Device Performance (Ambu aScope 4 Broncho System) |
|---|---|
| Compliance with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 594-1 | Declaration of Conformity with these product-specific standards. |
| Properties of bending angle, endurance, and radius of the bending section | Performance tests passed. |
| Depth of field | Performance tests passed. |
| Image quality (clearer visibility) | Performance tests passed. |
| Aging performance | Performance tests passed. |
| Sterile packaging integrity | Performance tests passed. |
| Electrical Compatibility (IEC 60601-1-2) | Performance tests passed. |
| Electrical Safety (IEC 60601-1 and IEC 60601-2-18) | Performance tests passed. |
| Functionality and intended use equivalence to predicate devices | Concluded to be equivalent/better than predicate devices. |
Note: The document explicitly states "Results: All tests were passed." for the listed performance data.
Explanation for Missing AI/ML Specific Information:
The device described (a flexible bronchoscope and monitor) is a traditional medical device, not an AI/ML powered one. Therefore, the questions related to AI/ML specific study design elements (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission.
The document indicates "Performance Data – Clinical: Not applicable," further confirming that this submission relies on bench testing and comparison to predicate devices, rather than clinical studies (which would be more common for software or AI/ML-driven devices needing to demonstrate clinical utility).
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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.
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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
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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 ETTinner diameter | MinimumDLT size | EA minimum workingchannel width | |
|---|---|---|---|
| aScope 3 Slim andaScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 RegularaScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 LargeaScope 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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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/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 72 25 20 00Fax.: +45 72 25 20 50 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contact Person | Name: Maja BrønsJob Title: Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 72 25 22 16Fax number: +45 72 25 20 50 | ||||||||||||
| Date SummaryPrepared | December 4, 2017 | ||||||||||||
| Device TradeName | Ambu® aScope™ 3 Slim 3.8/1.2Ambu® aScope™ 3 Regular 5.0/2.2Ambu® aScope™ 3 Large 5.8/2.8Ambu® aScope™ 4 Broncho Slim 3.8/1.2Ambu® aScope™ 4 Broncho Regular 5.0/2.2Ambu® aScope™ 4 Broncho Large 5.8/2.8Ambu® aView™ Monitor | ||||||||||||
| Device CommonName | Flexible Bronchoscope | ||||||||||||
| DeviceClassification | Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II | ||||||||||||
| LegallyMarketeddevices to whichthe device issubstantiallyequivalent | Predicate Manufacturer Trade Name 510k number A+B+C Ambu A/S Ambu® aScope™ 3 K161656 Reference D Vision-Science BRS-5000 VideoBronchoscope K091768 |
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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.
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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 ETTinnerdiameter | MinimumDLT size | EAminimumworkingchannelwidth | |
|---|---|---|---|
| aScope 3 Slim andaScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 RegularaScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 LargeaScope 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 referencedevices | 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. |
|---|---|
| PerformanceData -Bench | The following data are described for the product line extensionAmbu® 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.
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| PerformanceData – Clinical | Not applicable. |
|---|---|
| Conclusion | Based on the indication for use, technological characteristics,performance data and comparison to predicate and referencedevices it is concluded that the functionality and intended use ofAmbu® 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 Bronchoand Ambu® aView™ Monitor are as safe and effective and perform aswell as or better (regarding distal bending section/angulation range,depth of field and exposure for clearer visibility of the image) thanthe chosen legally marketed predicate and reference devices. |
§ 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.