(220 days)
Not Found
No
The description focuses on the physical characteristics and basic functionality of the endoscope and monitor, with no mention of AI, ML, or advanced image processing beyond simple display and recording.
Yes
The device is described as allowing "endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management," indicating it is used for diagnostic purposes and assists in medical procedures, fitting the definition of a therapeutic device.
Yes
The device is described as an endoscope used for "endoscopic observation to assess airway anatomy." This function directly supports making a medical diagnosis by allowing visualization and assessment of internal structures.
No
The device description clearly outlines both hardware components (Ambu aScope 3 endoscope with camera, LED, working channel, etc., and the Ambu aView Monitor) and their physical characteristics and performance. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for endoscopy within the airways and tracheobronchial tree for observation, intubation, and management. This is a direct examination of the patient's anatomy, not the testing of samples taken from the body.
- Device Description: The description details a system for visualizing the inside of the airways using a camera and light source. This is consistent with an endoscopic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical device used for direct visualization and intervention within the patient's body, which falls under a different regulatory category than IVDs.
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 within 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:
| Scope | Minimum ETT inner diameter | Minimum DLT, size |
|---|---|---|
| aScope 3 Slim 3.8/1.2 | 5.0mm | 37Fr |
| aScope 3 5.0/2.2 | 6.0mm | 41Fr |
Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5.
Endoscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.
Product codes
EOQ
Device Description
The system consists of Ambu aScope 3 ( Ambu aScope 3 5.0/2.2 or Ambu aScope 3 Slim 3.8/1.2) and Ambu aView Monitor.
Ambu aScope 3 has been designed for airway management within the larynx and the tracheobronchial tree. This includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management. Ambu aScope 3 is for single use and it is sterile.
The Ambu aScope 3 must be connected to Ambu aView Monitor. The monitor displays the image and it is reusable.
Ambu aScope 3 has the following physical and performance characteristics;
- Maneuverable tip controlled by the clinician
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Working channel
- Sterile by Ethylene Oxide sterilization
- For Single Use
The differences between Ambu aScope 3 5.0/2.2 and Ambu aScope 3 Slim 3.8/1.2 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 on the screen.
- Can record snapshot or video of image from aScope
- Can be fixed to e.g. an IV pole.
- 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, within the larynx and the 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
Ambu has provided declaration of conformity to the following recognized consensus standards applicable for this type of device:
- ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments - medical endoscopes and certain accessories.
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.
Result: All tests were passed.
Performance test report was submitted to document the following properties of the Ambu aScope 3 (single use):
- Bending angle and endurance of the bending section (accept criteria: bending to the maximum bending angle aScope 3 Slim 3.8/1.2; 130° up and down, aScope 3 5.0/2.2; 130° down and 150° up)
Result: All tests were passed.
Performance test report was submitted to document the following properties of the Ambu aView Monitor (reusable):
- Imaging performance; evaluation of colors, flickering, contrast l and haze, rated on a scale from 1-3, where 1 is best. (accept criteria: rating 1 and with a maximum of two ratings of 2)
Chemical endurance of Ambu aView Monitor (accept criteria: monitor can withstand the chemicals in contact with the monitor including cleaning and disinfection chemicals for reprocessing)
Battery capacity of Ambu aView Monitor (accept criteria: at least 70% battery capacity after 150 charging cycles)
Result: All tests were passed.
Performance test report was submitted to document Shelf life of Ambu aScope 3. Testing was done on finished, sterilized, shipped and aged products:
- Performance test of the Ambu aScope 3. Test according to Final Quality Inspection Procedure of Ambu aScope 3. Accept criteria: Product specifications fulfilled
- Sterile packaging integrity of the Ambu aScope 3 pouch. ー Accept criteria: The seal strength must be greater than 0.4 N when tested according to ASTM F88.
Result: All tests were passed
Environmental tests performed on aScope 3 5.0/2.2. aScope 3 Slim 3.8/1.2 and aView Monitor to demonstrate the compliance to the following standards:
Transportation in designated packaging:
- EN 60068-2-27 Basic environmental testing procedures Part 2: Tests - Test Ea and guidance: Shock: 500 repetitive shocks (bump) in each of 6 directions 400 m/s2 (40g)
- EN 60068-2-64 Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance: Random vibration 1.6 grms, 10-150Hz, 30 min/axis
- EN 60068-2-31 Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens: 12 falls from 1.2m height
Tests performed with the product without its packaging: Bounce - EN 60608-2-6 Environmental testing Part 2-6: Tests Test Fc: Vibration (sinusoidal): Sinus vibration 5Hz, 1grms, 1 hour.
Free fall - EN 60068-2-31 Environmenta! testing Part 2-31: Tests Test -Ec: Rough handling shocks; primarily for equipment-type specimens:
Ambu aScope 3: 2 falls per relevant orientation from 1.2m height to a smooth concrete surface.
After each of the above environmental tests, the packaging integrity and the device were inspected, and performance test of the device was performed.
Result: All products and packaging passed the tests.
Biocompatibility tests shows that the device complies with the requirements of ISO 10993-1:
- Cytotoxicity (ISO 10993-5) :
- Ethylene oxide sterilization residuals (ISO 10993-7) *
- Sensitization (ISO 10993-10)
- Intracutaneous reactivity test (ISO 10993-10)
Result: All tests were passed.
Tests that verify the following properties:
- Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation of the Ambu aView Monitor according to AAMI TIR12 and AAMI TIR30, to validate the prescribed method of cleaning and disinfection.
- Electro Magnetic Compatibility in compliance with IEC 60601-1-2.
- Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18.
Result: All tests were passed.
Performance Data -Clinical
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110962, K023984, K981543, K091768
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Application; K130845 – Ambu® aScope™ 3 and Ambu® aView
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 2055 | | | |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------|-------------|
| Contact Person | Name: Kaja Tengbjerg
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2215
Fax number: +45 7225 2050 | | | |
| Date Summary
Prepared | October 29, 2013 | | | |
| Device Trade
Name | Ambu® aScope™ 3 5.0/2.2
Ambu® aScope™ 3 Slim 3.8/1.2
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 | | Manufacturer | Trade Name | 510k number |
| | A: | Olympus
Corporation | Olympus BF Type 160 Video
Bronchoscope | K023984 |
| | B: | Olympus
Corporation | Olympus LF-TP Tracheal
Intubation Fiberscope | K981543 |
| | C: | Olympus
Corporation | Olympus LF-DP Tracheal
Intubation Fiberscope | K981543 |
| | D: | Vision
Sciences | BRS-5000 Flexible Digital
Video Bronchoscope | K091768 |
| | E: | Ambu A/S | Ambu aScope 2
and Ambu aScope Monitor | K110962 |
1
Description of the Device
The system consists of Ambu aScope 3 ( Ambu aScope 3 5.0/2.2 or Ambu aScope 3 Slim 3.8/1.2) and Ambu aView Monitor.
Ambu aScope 3 has been designed for airway management within the larynx and the tracheobronchial tree. This includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management. Ambu aScope 3 is for single use and it is sterile.
The Ambu aScope 3 must be connected to Ambu aView Monitor. The monitor displays the image and it is reusable.
Ambu aScope 3 has the following physical and performance characteristics;
- Maneuverable tip controlled by the clinician ・
- Flexible insertion cord .
- Camera and LED light source at the distal tip ・
- Working channel .
- Sterile by Ethylene Oxide sterilization •
- . For Single Use
The differences between_Ambu aScope 3 5.0/2.2 and Ambu aScope 3 Slim 3.8/1.2 are as follows:
- Distal end outer diameter י
- -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 on the screen. -
- Can record snapshot or video of image from aScope .
- Can be fixed to e.g. an IV pole. .
- 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 within 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:
| Scope | Minimum ETT inner diameter | Minimum DLT, size |
|---|---|---|
| aScope 3 Slim | ||
| 3.8/1.2 | 5.0mm | 37Fr |
| aScope 3 | ||
| 5.0/2.2 | 6.0mm | 41Fr |
Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5. Endoscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.
Version 3.0
Section 5 - Page 2 of 6
2
510(k) Application; K130845 - Ambu® aScope™ 3 and Ambu® aView™ Monitor
Summary of the technological characteristics in comparison to the predicate devices
Performance Data -
Bench
The Ambu aScope 3 System, consisting of Ambu aScope 3 and Ambu aView Monitor, is similar to the predicate devices in the following areas:
- They are all flexible endoscopes with a maneuverable tip -
- Predicate D and E are single-use devices, which are delivered . sterile
- Predicate D and E use a LED-light source located at the tip of the scopes
- Predicate A, D and E possess a camera located at the distal tip to provide an image
- They all have a handle with a control button giving the operator the ability to steer the tip of the scope up and down
- All devices can display an image on a separate monitor -
- Predicate device A, B, C, and D possess a suction port . equivalent to aScope 3
- The aScope 3's inner and outer diameters are within the same range as the predicate devices
Furthermore, Ambu aView Monitor is equivalent to aScope monitor, predicate E, on the following parameters:
- Both display a live image on a TFT-screen .
- Power is supplied to the endoscope via the connection to the . monitor
- Both are powered by a rechargeable battery or a power supply -Both systems can be operated either on battery or on mains . Dower
- Both monitors are portable
Ambu concludes that the Ambu aScope 3 and Ambu aView Monitor is substantially equivalent to the predicate devices.
The following data has been submitted in the premarket notification:
Ambu has provided declaration of conformity to the following recognized consensus standards applicable for this type of device:
- ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments - medical endoscopes and certain accessories.
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.
The declaration of conformity is based on test data. Result: All tests were passed.
Performance test report was submitted to document the following properties of the Ambu aScope 3 (single use):
- Bending angle and endurance of the bending section (accept criteria: bending to the maximum bending angle aScope 3 Slim 3.8/1.2; 130° up and down, aScope 3 5.0/2.2; 130° down and 150° up)
Result: All tests were passed.
Performance test report was submitted to document the following properties of the Ambu aView Monitor (reusable):
- Imaging performance; evaluation of colors, flickering, contrast l and haze, rated on a scale from 1-3, where 1 is best. (accept
Section 5 - Page 3 of 6
3
criteria: rating 1 and with a maximum of two ratings of 2) Chemical endurance of Ambu aView Monitor (accept criteria: monitor can withstand the chemicals in contact with the monitor including cleaning and disinfection chemicals for reprocessing)
Battery capacity of Ambu aView Monitor (accept criteria: at least 70% battery capacity after 150 charging cycles) Result: All tests were passed.
Performance test report was submitted to document Shelf life of Ambu aScope 3. Testing was done on finished, sterilized, shipped and aged products:
- Performance test of the Ambu aScope 3. Test according to Final । Quality Inspection Procedure of Ambu aScope 3. Accept criteria: Product specifications fulfilled
- Sterile packaging integrity of the Ambu aScope 3 pouch. ー Accept criteria: The seal strength must be greater than 0.4 N when tested according to ASTM F88.
Result: All tests were passed
Since the device is in compliance with the listed standards and has passed the listed performance tests, it is concluded that technological characteristics of Ambu aScope 3 and Ambu aView Monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate devices.
4
Environmental tests performed on aScope 3 5.0/2.2. aScope 3 Slim 3.8/1.2 and aView Monitor to demonstrate the compliance to the following standards:
Transportation in designated packaging:
- EN 60068-2-27 Basic environmental testing procedures Part 2: Tests - Test Ea and guidance: Shock: 500 repetitive shocks (bump) in each of 6 directions 400 m/s2 (40g)
- EN 60068-2-64 Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance: Random vibration 1.6 grms, 10-150Hz, 30 min/axis
- EN 60068-2-31 Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens: 12 falls from 1.2m height
Tests performed with the product without its packaging: Bounce
- EN 60608-2-6 Environmental testing Part 2-6: Tests Test Fc: Vibration (sinusoidal): Sinus vibration 5Hz, 1grms, 1 hour. Free fall
- EN 60068-2-31 Environmenta! testing Part 2-31: Tests Test -Ec: Rough handling shocks; primarily for equipment-type specimens:
Ambu aScope 3: 2 falls per relevant orientation from 1.2m height to a smooth concrete surface.
After each of the above environmental tests, the packaging integrity and the device were inspected, and performance test of the device was performed.
Result: All products and packaging passed the tests.
Based on the above environmental testing Ambu has concluded that Ambu aScope 3 and Ambu aView Monitor, can withstand the stresses applied to the product during transport and handling prior to the use of the device, and is as safe and effective and performs as well as or better than the chosen legally marketed predicate device.
5
Data for compliance to the general requirements for the device were submitted:
Biocompatibility tests shows that the device complies with the requirements of ISO 10993-1:
- Cytotoxicity (ISO 10993-5) :
- Ethylene oxide sterilization residuals (ISO 10993-7) *
- Sensitization (ISO 10993-10)
- Intracutaneous reactivity test (ISO 10993-10)
Result: All tests were passed.
Tests that verify the following properties:
- Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation of the Ambu aView Monitor according to AAMI TIR12 and AAMI TIR30, to validate the prescribed method of cleaning and disinfection.
- Electro Magnetic Compatibility in compliance with IEC 60601-1-2.
- Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18.
Result: All tests were passed.
Since the device passed all the tests to demonstrate compliance to the general requirements for this kind of device, it is concluded that Ambu aScope 3 and Ambu aView monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate devices.
Not applicable.
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 and Ambu aView Monitor is equivalent to the predicate devices.
It is concluded that Ambu aScope 3 and Ambu aView Monitor are as safe and effective and perform as well as or better than the chosen legally marketed predicate devices.
Performance Data -Clinical
Conclusion
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 1, 2013
Ambu A/S c/o Mr. Sanjay Parikh -VP Operations 6740 Baymeadow Dr. Glen Burnie, MD 21060
Re: K130845 ·
Trade/Device Name: Ambu® aScope™ 3 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aView™ Monitor Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) Regulatory Class: Class II Product Code: EOO Dated: September 27, 2013 Received: September 30, 2013
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.
7
Page 2 - Mr. Sanjay Parikh
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 device-related 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;
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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
8
Indications for Use
510(k) Number (if known): K130845
. Device Name: Ambu aScope™ 3 5.0/2.2 ... Ambu® aScope™ 3 Slim 3.8/1.2 Ambu a View ™
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 within 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:
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Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5.
Endoscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park
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