(189 days)
Not Found
No
The description focuses on the device's physical characteristics, visual output, and basic image display, with no mention of AI or ML for image analysis, decision support, or any other function.
No
The device is used as an aid in the placement of an Endotracheal Tube, providing visual guidance, rather than directly treating a disease or condition. While essential for a medical procedure, its function is diagnostic/guidance, not therapeutic.
No
The device is described as an aid in the placement of an Endotracheal Tube by providing visual confirmation of its tip's location. It is used for guidance and manipulation of the ETT, not for diagnosing conditions or diseases.
No
The device description clearly outlines both a hardware component (Ambu aScope with camera, light, and channel) and a separate hardware monitor (Ambu aScope Monitor) that displays the image. This is not a software-only device.
Based on the provided information, the Ambu aScope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Ambu aScope's Function: The Ambu aScope is a medical device used directly within the human body to aid in the placement of an endotracheal tube. It provides visual guidance of the anatomy in vivo, not through the analysis of a specimen in vitro.
- Intended Use: The intended use clearly states it's for aiding in the placement of an ETT by providing visual confirmation of the device's position within the human anatomy. This is a procedural aid, not a diagnostic test performed on a sample.
Therefore, the Ambu aScope falls under the category of a surgical or procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ambu aScope is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non difficult and difficult intubation procedures. The Ambu aScope achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope is in the human anatomy. The flexible tip of the Ambu aScope allows the user to guide the ETT in the desired direction.
The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.
Topical anesthetics can be administered via a channel with a luer connector
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
Ambu aScope System consist of Ambu aScope and Ambu aScope Monitor.
Ambu aScope is for placement of an endotracheal tube (ETT), an ETT size 6 or larger can be used. A camera at the distal tip of the aScope provides the user with an indication of the placement of the aScope. The manoeuvrable tip allows the user to guide the ETT in the desired direction. Ambu aScope is for single patient use and it is sterile.
The Ambu aScope must be connected to Ambu aScope Monitor. The monitor displays the image and it is reusable.
Ambu aScope has the following physical and performance characteristics:
- Manoeuvrable tip controlled by the clinician
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Topical Anaesthetics can be administered to the patient via a channel, with standard luer connector
- Sterile by Ethylene Oxide sterilisation
- For Single Patient Use
Ambu aScope Monitor has the following physical and performance characteristics:
- Displays the image from Ambu aScope on the screen.
- Can be fixed to e.g. an IV pole.
- By connecting a Video Out Cable to the Ambu aScope Monitor the image can be displayed and/or recorded on an external monitor and/or video recorder.
- Reusable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (CMOS camera)
Anatomical Site
Human anatomy for Endotracheal Tube placement.
Indicated Patient Age Range
adults/children
Intended User / Care Setting
Use in a 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 studies were performed.
- 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 (single use):
- Manoeuvrability of tip (accept criteria: min 120 ° to each side)
- Endurance of the bending section (accept criteria: 50 bends to each side of minimum 90° and 10 bends to each side of minimum 120°)
- Channel for topical anaesthetics (accept criteria: verification of ability to administer topical anaesthetics through the channel - when 1 ml is injected at least 0.8 ml was expelled in the distal end)
- Temperature at distal end of Ambu aScope (accept criteria: temperature below 41 °C)
Result: All tests were passed.
- Performance test report was submitted to document the following properties of the Ambu aScope Monitor (reusable):
- Imaging performance; evaluation of colours, flickering, contrast and brightness, rated on a scale from 1-3, where 1 is best. (accept criteria: rating 1 and max 2 ratings of 2, when 32 scopes are evaluated for all 4 properties (128 evaluations))
- Cleaning endurance of aScope Monitor (accept criteria: monitor can withstand the prescribed cleaning and disinfection method for 150 times reprocessing)
- Battery capacity of Ambu aScope Monitor (accept criteria: at least 70% battery capacity after 150 times charging and de-charging)
Result: All tests were passed.
- Performance test report was submitted to document Shelf life of Ambu aScope. Testing was done on finished, sterilized, shipped and aged products:
- Performance test of the aScope. Test according to Final Quality Inspection Procedure of Ambu aScope. Accept criteria: Product specifications fulfilled
- Sterile packaging integrity of the aScope pouch. 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 were conducted demonstrating compliance to standards for:
- Transportation in designated packaging (EN 60068-2-27, EN 60068-2-64, EN 60068-2-31)
- Tests performed with the product without its packaging (EN 60608-2-6, EN 60068-2-31)
Result: All products and packaging passed the tests.
- Biocompatibility tests demonstrate compliance with ISO 10993-1: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity test (ISO 10993-10).
Result: All tests were passed. - Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation of the Ambu aScope Monitor according to AAMI TIR12 and AAMI TIR30.
Result: All tests were passed. - Electro Magnetic Compatibility in compliance with IEC 60601-1-2.
Result: All tests were passed. - Electrical Safety in compliance with IEC 60601-1 and IEC -60601-2-18.
Result: All tests were passed.
Clinical Performance Data - 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.
K090777, K052233, K023984, K850978
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
・リ
510(k) Application – Ambu® aScope™ and Ambu® aScope™ Monitor
APR 1 👍 2010
Section 7 - 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: Lai la Strange Lundtoft
Job Title: Regulatory Affairs Manager
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2217
Fax number: +45 7225 2055 | | |
| Date Summary
Prepared | September 30, 2009 | | |
| Device Trade Name | Ambu® aScope™
Ambu® aScope™ Monitor | | |
| Device Common Name | Endoscope for endotracheal intubation | | |
| Device Classification | Tracheal Tube
Product Code: BTR
21 CFR 868.5730
Class II | | |
| Legally Marketed
devices to which the
device is substantially
equivalent | Manufacturer | Trade Name | 510k
number |
| | Olympus | Olympus Bronchoscope
BF-160 | K023984 |
| | Olympus | Olympus LF-1 Tracheal
intubation fiberscope | K850978 |
| | ETView Ltd | Traceoscopic Ventilation
Tube System | K052233 |
| | EZC | EZC Medical, LLC,
IntubaidFlex | K090777 |
.
Section 7 - Page 1 of 6
1
| Description of the
Device | Ambu aScope System consist of Ambu aScope and Ambu
aScope Monitor.
Ambu aScope is for placement of an endotracheal tube (ETT),
an ETT size 6 or larger can be used. A camera at the distal tip of
the aScope provides the user with an indication of the
placement of the aScope. The manoeuvrable tip allows the user
to guide the ETT in the desired direction. Ambu aScope is for
single patient use and it is sterile.
The Ambu aScope must be connected to Ambu aScope Monitor.
The monitor displays the image and it is reusable. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ambu aScope has the following physical and performance
characteristics:
- Manoeuvrable tip controlled by the clinician
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Topical Anaesthetics can be administered to the patient via
a channel, with standard luer connector - Sterile by Ethylene Oxide sterilisation
- For Single Patient Use
Ambu aScope Monitor has the following physical and
performance characteristics:
- Displays the image from Ambu aScope on the screen.
- Can be fixed to e.g. an IV pole.
- By connecting a Video Out Cable to the Ambu aScope
Monitor the image can be displayed and/or recorded on an
external monitor and/or video recorder. - Reusable device. |
| Intended use | The Ambu aScope is intended for use as an aid in the placement
of an Endotracheal Tube (ETT) directly or through an intubating
laryngeal mask during non-difficult and difficult intubation
procedures.
The Ambu aScope achieves its purpose by providing the user
with a visual confirmation of where the tip of the Ambu aScope
is in the human anatomy. The flexible tip of the Ambu aScope
allows the user to guide the ETT in the desired direction.
The system is for use in a hospital environment. The target
population is adults/children that have been clinically evaluated
for ETT size 6 or larger.
Topical anesthetics can be administered via a channel with a
luer connector. |
: : :
.
2
Summary of the technological characteristics in comparison to the predicate devices
Ambu aScope is similar to EZC Medical LCC, Intubaid Flex (K090777) in the following areas;
- They possess a similar Indication for Use. �
- None of the devices possess a suction port.
- They both are flexible scopes with a manoeuvrable tip.
- They are single-use devices, which are delivered sterile.
- They both use a LED-light source located at the tip of the scopes
- They possess a CMOS camera located at the distal tip to provide an image
- . They have a handle with a control button giving the operator the ability to steer the tip of the scope up and down
- In both devices, an image is provided on a separate . monitor
Ambu aScope is similar to ETView, Tracheoscopic Ventilation Tube (TVT) System (K052233) in the following areas:
- It uses LED as light source located at the tip of the . scopes
- . A CMOS camera at the distal tip to provide an image
- . It is a single use device, which is delivered sterile.
- None of the devices possess a suction port.
They are different in design in that TVT is an Endotracheal Tube by it self, Ambu aScope is an aid in the placement of the ETT. As well TVT does not have manoeuvrable tip as the Ambu aScope.
Ambu aScope system is similar to Olympus Bronchoscope, BF-160 (K023984) and Olympus LF-1 Tracheal intubation fiberscope (K850978) in that it consist of:
- A handle with a control button giving the operator the . ability to steer the tip of the scope up and down
- It is possible to apply topical anesthesia at the tip of the insertion cord
- · · Light source at the tip
- An image is provided at a monitor
- Used for tracheal intubation for insertion and navigation into the trachea and easier placement of endotracheal tubes
The Ambu aScope System is based on the same basic principles and design and will fit in on all the characteristics, except that it is using LED as a light source and a CMOS camera at the distal tip to provide images. Moreover Ambu aScope is a single use device.
Ambu concludes that the Ambu aScope and Ambu aScope Monitor is substantially equivalent to the predicate devices.
3
.
| Performance Data -
| Bench | 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 (single use): - Manoeuvrability of tip (accept criteria: min 120 ° to each side)
- Endurance of the bending section (accept criteria: 50 bends to
each side of minimum 90° and 10 bends to each side of
minimum 120°) - Channel for topical anaesthetics (accept criteria: verification of
ability to administer topical anaesthetics through the channel -
when 1 ml is injected at least 0.8 ml was expelled in the distal |
| | end) - Temperature at distal end of Ambu aScope (accept criteria:
temperature below 41 °C)
Result: All tests were passed. |
| | Performance test report was submitted to document the following
properties of the Ambu aScope Monitor (reusable): - Imaging performance; evaluation of colours, flickering, contrast
and brightness, rated on a scale from 1-3, where 1 is best.
(accept criteria: rating 1 and max 2 ratings of 2, when 32 scopes
are evaluated for all 4 properties (128 evaluations)) - Cleaning endurance of aScope Monitor (accept criteria: monitor
can withstand the prescribed cleaning and disinfection method
for 150 times reprocessing) - Battery capacity of Ambu aScope Monitor (accept criteria: at
least 70% battery capacity after 150 times charging and de-
charging)
Result: All tests were passed. |
| | Performance test report was submitted to document Shelf life of
Ambu aScope. Testing was done on finished, sterilized, shipped and
aged products: - Performance test of the aScope. Test according to Final Quality
Inspection Procedure of Ambu aScope.
Accept criteria: Product specifications fulfilled - Sterile packaging integrity of the aScope pouch.
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 have
passed the listed performance tests, it is concluded that technological
characteristics of Ambu aScope and Ambu aScope Monitor is as safe
and effective and performs as well as or better than the chosen
legally marketed predicate devices. |
Version 3.2.1
.
.
4
Environmental tests 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 quidance: 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 equipmenttype 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 l Fc: Vibration (sinusoidal): Sinus vibration 5Hz, 1grms, 1 hour.
Free fall -
l EN 60068-2-31 Environmental testing - Part 2-31: Tests -Test Ec: Rough handling shocks, primarily for equipmenttype specimens:
- aScope: 2 falls per relevant orientation from 1.2m height to a smooth concrete surface.
- aScope Monitor: 2 falls per relevant orientation from 0.2m 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 and Ambu aScope 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 devices.
5
were submitted: Biocompatibility tests shows that the device complies with the requirements of ISO 10993-1: Cytotoxicity (ISO 10993-5) -- S ensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed. Tests that verifies the following properties: Cleaning validation and Liquid Chemical Sterilization and l Disinfection Validation of the Ambu aScope 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 and Ambu aScope monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate devices. Performance Data -Not applicable. Clinical Based on the indication for use, technological characteristics, Conclusion performance data and comparison to predicate devices it has been concluded that the Ambu aScope and Ambu aScope Monitor has equivalent functionality and intended use as the predicate devices. It is concluded that Ambu aScope and Ambu aScope Monitor are as safe and effective and performs as well as or better than the chosen legally marketed predicate devices.
Data for compliance to the general requirements for the device
Version 3.2 .1
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling the symbol. The symbol is a stylized caduceus, a staff with two snakes entwined around it, which is often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1
Ambu A/S C/O Mr. Sanjay Parikh Vice President Operations Ambu, Incorporated 6740 Baymeadow Drive Glen Burnie, Maryland 21060
Re: K093186
Trade/Device Name: Ambu aScope™ and Ambu® aScope™ Monitor Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: April 09, 2010 Received: April 12, 2010
Dear Mr. 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.
ﺘ
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.
If 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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K093186
Device Name: Ambu aScope 1 and Ambu aScope™ Monitor
Indications For Use:
The Ambu aScope is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non difficult and difficult intubation procedures. The Ambu aScope achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope is in the human anatomy. The flexible tip of the Ambu aScope allows the user to guide the ETT in the desired direction.
The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.
Topical anesthetics can be administered via a channel with a luer connector
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Shult
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093186
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