(27 days)
No
The description focuses on the physical components and functionality related to visualization, instrument passage, and fluid sample collection. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is intended for visualization, examination, aspiration, and collection of fluid samples, which are diagnostic and procedural functions, not therapeutic. While it allows for passing "endotherapy instruments," the device itself does not perform therapeutic actions.
No
The device is primarily intended for visualization during endoscopic procedures and for facilitating the collection of fluid samples. While these samples may be used for a diagnostic purpose, the device itself is a tool for obtaining the sample or visualizing, not for performing the diagnosis.
No
The device description clearly outlines multiple hardware components including the endoscope, sample containers, tubes, and adapters. The performance studies also focus on physical and functional testing of these hardware components.
Based on the provided information, the Ambu® aScope™ 5 Broncho HD Sampler Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for endoscopic procedures and examination within the airways and tracheobronchial tree, providing visualization, allowing passage of instruments, and enabling aspiration and collection of fluid samples. This describes a device used in vivo (within the body) for diagnostic and procedural purposes, not a device used in vitro (outside the body) to examine specimens.
- Device Description: The description details a flexible endoscope and accessories for collecting samples during the endoscopic procedure. The sample containers are for collecting fluid samples aspirated from the airways.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens outside the body to provide diagnostic information. The device facilitates the collection of samples, but it does not perform any analysis or testing on those samples itself.
- Predicate Device: The predicate device (K220606; Ambu® aScope™ 5 Broncho HD) is also an endoscope, which is not an IVD device.
In summary, the Ambu® aScope™ 5 Broncho HD Sampler Set is a medical device used for visualization and sample collection during a medical procedure performed on a patient. It does not perform in vitro analysis of biological specimens.
N/A
Intended Use / Indications for Use
Ambu® aScope™ 5 Broncho HD Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD Sampler Set is intended to provide visualization via a compatible Ambu displaying unit. and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho HD Sampler Set enables aspiration and collection of fluid samples.
Product codes
EOQ
Device Description
The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:
Ambu® aScope™ 5 Broncho HD Two Sample Containers (aScope BronchoSampler™ 60 SC) Suction Connection Tube (SCT) Bronchoscope Attachment Part (BAP) 2 Luer lock adapters (introducers)
Ambu® aScope™ 5 Broncho HD is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples.
The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set.
The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source.
The Sample Container Ambu® BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.
The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.
The Ambu® BronchoSampler™ 60 SC plus an additional Sampler Container, BAP, SCT and two introducers will be packaged and sterilized together with a aScope 5 Broncho HD endoscope to form a self-contained set, the aScope 5 Broncho HD Sampler Set.
There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
- a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
- b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope 5 Broncho HD endoscope tip . controlled by the user
- Flexible Ambu® aScope 5 Broncho HD endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope 5 Broncho HD endoscope
- . Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection ●
The following characteristic of the endoscope varies between sizes:
- Distal end outer diameter
- Insertion tube outer diameter
- Working channel inner diameter ●
- . Angulation range
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests related to the modifications was performed to document the following properties of the modification to Ambu® aScope™ 5 Broncho HD.
In addition to the non-clinical performance testing documented for the Ambu® aScope™ 5 Broncho HD (K220606), additional bench testing has been performed in accordance with ISO 14971 as Design Verification of those Design Input requirements that are specified as risk control measures for those risks arising from the addition of sampling functionality to the endoscope. A table of this special 510(k) cross references these additional risks, documented in the Product Risk Evaluation for the Ambu® aScope™ 5 Broncho Sampler Set, with the risk control measures and the subsequent verification results.
A summary of the methods to verify the additional requirements and identified risks arising from the risk control measures are as follows:
• Transportation testing
• Packaging testing
• Suction Testing
• Connectivity testing
• Tests for basic function of BronchoSampler 60
• Biological evaluation
• Sterilization Validation
Result: All requirements are verified successfully.
Clinical Performance Data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2023
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, suite 200 Columbia, Maryland 21046
Re: K223782
Trade/Device Name: Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 12, 2022 Received: December 16, 2022
Dear Sanjay Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223782
Device Name
Ambu® aScope™ 5 Broncho HD 5.6/2.8 Sampler Set Ambu® aScope™ 5 Broncho HD 5.0/2.2 Sampler Set
Indications for Use (Describe)
Ambu® aScope™ 5 Broncho HD Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD Sampler Set is intended to provide visualization via a compatible Ambu displaying unit. and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho HD Sampler Set enables aspiration and collection of fluid samples.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This Special 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summary has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 | | | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------|-----------------------------|
| Contact Person | Name: Kristian Moltved
Job Title: Associate Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, 2750 Ballerup
Telephone number: +45 7225 2116
Fax number: +45 7225 2050 | | | |
| Date Summary
Prepared | December 12, 2022 | | | |
| Device Trade
Name | Ambu® aScope™ 5 Broncho HD 5.6/2.8 Sampler Set
Ambu® aScope™ 5 Broncho HD 5.0/2.2 Sampler Set | | | |
| Device Common
Name | Flexible Endoscope and Specimen Sampling System - Single Use | | | |
| Device
Classification | Ambu® aScope™ 5 Broncho HD Sampler Set:
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 | Predicate | Manufacturer
Ambu A/S | Trade Name
Ambu® aScope™
5 Broncho HD | 510(k)
number
K220606 |
4
| Description of
the Device | The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:
Ambu® aScope™ 5 Broncho HD Two Sample Containers (aScope BronchoSampler™ 60 SC) Suction Connection Tube (SCT) Bronchoscope Attachment Part (BAP) 2 Luer lock adapters (introducers) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ambu® aScope™ 5 Broncho HD is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. |
| | The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples. |
| | The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set. |
| | The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source. |
| | The Sample Container Ambu® BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure. |
| | The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored. |
5
The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.
The Ambu® BronchoSampler™ 60 SC plus an additional Sampler Container, BAP, SCT and two introducers will be packaged and sterilized together with a aScope 5 Broncho HD endoscope to form a self-contained set, the aScope 5 Broncho HD Sampler Set.
There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
- a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
- b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope 5 Broncho HD endoscope tip . controlled by the user
- Flexible Ambu® aScope 5 Broncho HD endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope 5 Broncho HD endoscope
- . Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection ●
The following characteristic of the endoscope varies between sizes:
- Distal end outer diameter
- Insertion tube outer diameter
- Working channel inner diameter ●
- . Angulation range
6
| Indications for
Use | Ambu® aScope™ 5 Broncho HD Sampler Set is intended for
endoscopic procedures and examination within the airways and
tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD Sampler Set is intended to
provide visualization via a compatible Ambu displaying unit and to
allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho HD Sampler Set enables aspiration
and collection of fluid samples. |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of the
technological
characteristics
in comparison to
the predicate
device | The Ambu® aScope™ 5 Broncho HD endoscope in the Ambu®
aScope™ 5 HD Broncho Sampler Set is identical to the predicate. |
| | Ambu® aScope™ 5 Broncho HD Sampler Set differs from the
predicate in the following areas:
Ambu® aScope™ BronchoSampler 60 SC, BAP, SCT and
two introducers are added to the Ambu® aScope™ 5
Broncho HD endoscope. Ambu® aScope™ BronchoSampler 60 SC, BAP, SCT and
two introducers are packaged and sterilized together with
aScope 5 Broncho HD endoscopes to form a self-contained
set, the Ambu® aScope™ 5 Broncho HD Sampler Set. |
| Performance
Data -Bench | Performance tests related to the modifications was performed to
document the following properties of the modification to Ambu®
aScope™ 5 Broncho HD.
In addition to the non-clinical performance testing documented for
the Ambu® aScope™ 5 Broncho HD (K220606), additional bench
testing has been performed in accordance with ISO 14971 as
Design Verification of those Design Input requirements that are
specified as risk control measures for those risks arising from the
addition of sampling functionality to the endoscope. A table of this
special 510(k) cross references these additional risks, documented
in the Product Risk Evaluation for the Ambu® aScope™ 5 Broncho
Sampler Set, with the risk control measures and the subsequent
verification results. |
| | A summary of the methods to verify the additional requirements
and identified risks arising from the risk control measures are as
follows:
• Transportation testing
• Packaging testing
• Suction Testing
• Connectivity testing
• Tests for basic function of BronchoSampler 60
• Biological evaluation
• Sterilization Validation
Result: All requirements are verified successfully. |
| Performance
Data - Clinical | Not applicable. |
| Conclusion | The Ambu® aScope™ 5 Broncho Sampler Set has the same
intended use and indications for use, and similar technological
characteristics and principles of operation as the predicate device. |
| | It is concluded that Ambu® aScope™ 5 Broncho Sampler Set is
substantial equivalent to its predicate device. |
7