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

K161656 · Ambu A/S · EOQ · Sep 1, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: 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
• Applicant: Ambu A/S
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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: [Table data: aScope 3 Slim 3.8/1.2: 5.0 mm ETT, 37 Fr DLT; aScope 3 Regular 5.0/2.2: 6.0 mm ETT, 41 Fr DLT; aScope 3 Large 5.8/2.8: 7.0 mm ETT]. 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.

Device Story

System comprises sterile, single-use flexible bronchoscopes (aScope 3 Slim, Regular, Large) and reusable aView monitor. Bronchoscopes feature maneuverable distal tip, LED light source, camera, and working channel for endotherapy accessories. Used in hospital settings by clinicians for airway/tracheobronchial tree visualization. Monitor displays real-time video from endoscope; supports snapshot/video recording and external monitor connection. Provides visual guidance for procedures; assists in airway management and diagnostic/therapeutic interventions. Single-use design eliminates reprocessing requirements.

Clinical Evidence

No clinical data. Bench testing only, including ISO 8600-1, 8600-3, 8600-4, and 594-1 compliance, bending angle/endurance, aging, sterile packaging integrity, and electrical safety/compatibility (IEC 60601-1, 60601-2-18, 60601-1-2).

Technological Characteristics

Flexible video bronchoscope; LED light source at distal tip; CMOS camera; working channel for accessories. Sterilized by Ethylene Oxide. Connectivity: proprietary connection to aView monitor; external monitor output. Standards: ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 594-1, IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2.

Indications for Use

Indicated for endoscopy of the airways and tracheobronchial tree in adults in a hospital environment.

Regulatory Classification

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.

Predicate Devices

• Ambu aScope 3 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2 and Ambu aView (K130845)
• Olympus BF-1TH190 Video Bronchoscope (K121959)

Submission Summary (Full Text)

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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.

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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 (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 [phone] or [phone] 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 [phone] or [phone] 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<br>Baltorpbakken 13<br>DK-2750 Ballerup<br>Denmark<br>Tel.: [phone]<br>Fax.: [phone] | | | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------|------------------------|
| Contact Person | Name: Camilla Wismar<br>Job Title: Senior Regulatory Affairs Professional<br>Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup<br>Telephone number: [phone]<br>Fax number: [phone] | | | |
| Date Summary Prepared | June 7, 2016 | | | |
| Device Trade Name | Ambu® aScope™ 3 Regular 5.0/2.2<br>Ambu® aScope™ 3 Slim 3.8/1.2<br>Ambu® aScope™ 3 Large 5.8/2.8<br>Ambu® aView™ Monitor | | | |
| Device Common Name | Flexible Bronchoscope | | | |
| Device Classification | Bronchoscope (flexible or rigid) and accessories<br>Product Codes: EOQ<br>21 CFR 874.4680<br>Class II | | | |
| Legally Marketed devices to which the device is substantially equivalent | A+B: | Manufacturer<br>Ambu A/S | Trade Name<br>Ambu® aScope 3™ 5.0/2.2, Ambu®<br>aScope™ 3 Slim 3.8/1.2<br>and Ambu® aView | 510k number<br>K130845 |
| | C: | Olympus Corporation | Olympus BF-1TH190<br>Video Bronchoscope | K121959 |

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| Description of the Device | The Ambu® aScope™ 3 System consists of:<br>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.<br><br>Ambu® aScope™ 3 endoscopes has the following physical and performance characteristics:<br>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:<br>Distal end outer diameter Insertion tube outer diameter Working channel inner diameter Angulation range Ambu® aView™ Monitor has the following physical and performance characteristics:<br>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.<br><br>The aScope 3 system is for use in a hospital environment.<br><br>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<br>technological<br>characteristics<br>in comparison<br>to the predicate<br>devices | Endoscopic accessories designed for a minimum working channel<br>width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.<br>Endoscopic accessories designed for a minimum working channel<br>width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.<br>Endoscopic accessories designed for a minimum working channel<br>width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.<br>Ambu® aScope™ 3 Regular, Ambu® aScope™ Slim and Ambu®<br>aView™ are similar to predicate devices described in K130485.<br>The product line extension Ambu® aScope™ 3 Large 5.8/2.8 is similar<br>to the predicate devices in the following areas:<br>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<br>Data -Bench | The following data are described for the product line extension Ambu®<br>aScope™ 3 Large in the premarket notification:<br>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<br>Data - Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics,<br>performance data and comparison to predicate devices it has been<br>concluded that the functionality and intended use of Ambu® aScope™<br>3 Regular 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aScope™<br>3 Large 5.8/2.8 and Ambu® aView™ Monitor is equivalent to the<br>predicate devices.<br><br>It is concluded that Ambu® aScope™ 3 Regular 5.0/2.2, Ambu®<br>aScope™ 3 Slim 3.8/1.2, Ambu® aScope™ 3 Large 5.8/2.8 and<br>Ambu® aView™ Monitor are as safe and effective and perform as well<br>as or better than the chosen legally marketed predicate devices. |

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