(189 days)
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
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.
Ambu aScope and aScope Monitor 510(k) Summary (K093186)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document primarily relate to the physical and performance characteristics of the Ambu aScope and Ambu aScope Monitor, as well as adherence to recognized consensus standards. There is no specific acceptance criteria for diagnostic accuracy or clinical outcomes that would typically be seen for AI/ML devices. Instead, the focus is on the device's functionality, durability, safety, and manufacturing quality.
| Acceptance Criteria (Ambu aScope) | Reported Device Performance |
|---|---|
| Manoeuvrability of tip: min 120° to each side | All tests were passed (implies criteria met). |
| Endurance of bending section: 50 bends to each side of minimum 90° and 10 bends to each side of minimum 120° | All tests were passed (implies criteria met). |
| Channel for topical anaesthetics: when 1 ml injected, at least 0.8 ml expelled at distal end | Verification of ability to administer topical anaesthetics through the channel was passed (implies criteria met). |
| Temperature at distal end of Ambu aScope: below 41 °C | All tests were passed (implies criteria met). |
| Shelf life: Product specifications fulfilled (after aging) | All tests were passed (implies criteria met). |
| Sterile packaging integrity: Seal strength > 0.4 N (ASTM F88) | All tests were passed (implies criteria met). |
| Acceptance Criteria (Ambu aScope Monitor) | Reported Device Performance |
|---|---|
| Imaging performance: rating 1, and max 2 ratings of 2 (on a scale of 1-3 where 1 is best) when 32 scopes evaluated for 4 properties (128 evaluations) | All tests were passed (implies criteria met). |
| Cleaning endurance: withstand prescribed cleaning/disinfection 150 times | All tests were passed (implies criteria met). |
| Battery capacity: at least 70% capacity after 150 charging/discharging cycles | All tests were passed (implies criteria met). |
| Acceptance Criteria (General/Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance to ISO 8600-1, ISO 8600-3, ISO 8600-4 (Optics and optical instruments - medical endoscopes) | Declaration of conformity based on test data. All tests were passed. |
| Compliance to ISO 594-1 (Conical fittings - luer taper) | Declaration of conformity based on test data. All tests were passed. |
| Biocompatibility: Compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity) | All tests were passed. |
| Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation: According to AAMI TIR12 and AAMI TIR30 | All tests were passed. |
| Electro Magnetic Compatibility: Compliance with IEC 60601-1-2 | All tests were passed. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-18 | All tests were passed. |
| Environmental (Transport, Handling, Free Fall) tests: Compliance with EN 60068-2-27, EN 60068-2-64, EN 60068-2-31, EN 60608-2-6 (specific parameters detailed in the document) | All products and packaging passed the tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI/ML device evaluating data. Instead, it refers to performance tests on the physical device.
- Ambu aScope: No specific "sample size" is mentioned for individual components, but tests were conducted on various units to verify physical and performance characteristics, endurance, and shelf life.
- Ambu aScope Monitor: For "Imaging performance," 32 scopes were evaluated, leading to 128 evaluations (32 scopes x 4 properties). No information is provided regarding the origin or retrospective/prospective nature of this data as it relates to device functionality rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The document describes engineering and physical performance tests, and compliance with standards, not a study involving experts to establish ground truth for image or diagnostic data interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements or pass/fail criteria based on engineering specifications and recognized standards, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical intubation scope and monitor system, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering specifications, physical benchmarks, and recognized consensus standards (e.g., ISO, IEC, ASTM) which define acceptable ranges or outcomes for various physical and functional tests.
8. The Sample Size for the Training Set
Not applicable. This device does not involve AI/ML and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve AI/ML and therefore does not have a "training set" or corresponding ground truth establishment process in that context.
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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/SBaltorpbakken 13DK-2750 BallerupDenmarktel.: +45 7225 2000fax.: +45 7225 2055 | ||
|---|---|---|---|
| Contact Person | Name: Lai la Strange LundtoftJob Title: Regulatory Affairs ManagerAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2217Fax number: +45 7225 2055 | ||
| Date SummaryPrepared | September 30, 2009 | ||
| Device Trade Name | Ambu® aScope™Ambu® aScope™ Monitor | ||
| Device Common Name | Endoscope for endotracheal intubation | ||
| Device Classification | Tracheal TubeProduct Code: BTR21 CFR 868.5730Class II | ||
| Legally Marketeddevices to which thedevice is substantiallyequivalent | Manufacturer | Trade Name | 510knumber |
| Olympus | Olympus BronchoscopeBF-160 | K023984 | |
| Olympus | Olympus LF-1 Trachealintubation fiberscope | K850978 | |
| ETView Ltd | Traceoscopic VentilationTube System | K052233 | |
| EZC | EZC Medical, LLC,IntubaidFlex | K090777 |
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Section 7 - Page 1 of 6
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| Description of theDevice | Ambu aScope System consist of Ambu aScope and AmbuaScope 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 ofthe aScope provides the user with an indication of theplacement of the aScope. The manoeuvrable tip allows the userto guide the ETT in the desired direction. Ambu aScope is forsingle 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 performancecharacteristics:- 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 viaa channel, with standard luer connector- Sterile by Ethylene Oxide sterilisation- For Single Patient UseAmbu aScope Monitor has the following physical andperformance 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 aScopeMonitor the image can be displayed and/or recorded on anexternal monitor and/or video recorder.- Reusable device. | |
| Intended use | The Ambu aScope is intended for use as an aid in the placementof an Endotracheal Tube (ETT) directly or through an intubatinglaryngeal mask during non-difficult and difficult intubationprocedures.The Ambu aScope achieves its purpose by providing the userwith a visual confirmation of where the tip of the Ambu aScopeis in the human anatomy. The flexible tip of the Ambu aScopeallows the user to guide the ETT in the desired direction.The system is for use in a hospital environment. The targetpopulation is adults/children that have been clinically evaluatedfor ETT size 6 or larger.Topical anesthetics can be administered via a channel with aluer connector. |
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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.
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| Performance Data -Bench | The following data has been submitted in the premarket notification: |
|---|---|
| Ambu has provided declaration of conformity to the followingrecognized consensus standards applicable for this type of device:- ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and opticalinstruments - 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 followingproperties 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 toeach side of minimum 90° and 10 bends to each side ofminimum 120°)- Channel for topical anaesthetics (accept criteria: verification ofability 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 followingproperties of the Ambu aScope Monitor (reusable):- Imaging performance; evaluation of colours, flickering, contrastand brightness, rated on a scale from 1-3, where 1 is best.(accept criteria: rating 1 and max 2 ratings of 2, when 32 scopesare evaluated for all 4 properties (128 evaluations))- Cleaning endurance of aScope Monitor (accept criteria: monitorcan withstand the prescribed cleaning and disinfection methodfor 150 times reprocessing)- Battery capacity of Ambu aScope Monitor (accept criteria: atleast 70% battery capacity after 150 times charging and de-charging)Result: All tests were passed. | |
| Performance test report was submitted to document Shelf life ofAmbu aScope. Testing was done on finished, sterilized, shipped andaged products:- Performance test of the aScope. Test according to Final QualityInspection 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 Nwhen tested according to ASTM F88.Result: All tests were passed | |
| Since the device is in compliance with the listed standards and havepassed the listed performance tests, it is concluded that technologicalcharacteristics of Ambu aScope and Ambu aScope Monitor is as safeand effective and performs as well as or better than the chosenlegally marketed predicate devices. |
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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
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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.
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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
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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.
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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
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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
Page 1 of
§ 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).