(26 days)
Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho 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 Sampler Set enables aspiration and collection of fluid samples.
The Ambu® aScope™ 5 Broncho Sampler Set consists of:
- Ambu® aScope™ 5 Broncho endoscope .
- Two Sample Containers (Ambu® aScope BronchoSampler™ 60 SC)
- Suction Connection Tube (SCT)
- Bronchoscope Attachment Part (BAP)
- 2 Luer lock adapters (Introducers) .
Ambu® aScope™ 5 Broncho 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 (K230428).
The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.
The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.
BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.
The Ambu® aScope 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 endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing.
The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.
Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope™ 5 Broncho endoscope tip controlled by the user
- Flexible Ambu® aScope™ 5 Broncho endoscope insertion cord
- Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
- Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection in BAL and BW procedures
The provided document is a 510(k) summary for the Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance benchmarks. Therefore, many of the requested categories are "Not Applicable" or information is unavailable from this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format requested for a software device or diagnostic tool. Instead, it lists types of bench testing performed to verify design input requirements related to safety and functionality due to the addition of sampling functionality.
| Acceptance Criteria Category | Reported Device Performance / Verification Status |
|---|---|
| Transportation Testing | Performed. Results indicate successful verification. |
| Packaging Testing | Performed. Results indicate successful verification. |
| Suction Testing | Performed. Results indicate successful verification. |
| Connectivity Testing | Performed. Results indicate successful verification. |
| Basic Function of | Performed. Results indicate successful verification for BronchoSampler 60. |
| BronchoSampler 60 | |
| Biological Evaluation | Performed. Results indicate successful verification (implied to meet biocompatibility/safety standards). |
| Sterilization Validation | Performed. Results indicate successful verification (ensuring sterility for single-use device). |
| Overall Conclusion | All requirements are verified successfully. The device has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing" without detailing the number of units or tests conducted for each category.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility (Ambu A/S, Denmark) or a contracted lab. The data is prospective in the sense that the tests were designed and executed to verify the new product's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical instrument (bronchoscope and sampling set), not an AI/diagnostic software. Ground truth in this context would refer to objective physical and chemical measurements or engineering standards, not expert medical consensus on images or data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not relevant for bench testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a physical medical device, not an AI software intended to assist human readers in interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm. The device, as a physical product, operates as described (e.g., provides visualization, allows instrument passing, enables aspiration), and its performance is verified through physical and functional testing.
7. The Type of Ground Truth Used
The ground truth used for bench testing typically involves:
- Engineering specifications and design input requirements.
- Industry standards (e.g., ISO for biological evaluation, sterilization).
- Physical measurements (e.g., suction pressure, flow rates, dimensions).
- Functional checks (e.g., maneuverability, connectivity).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device.
§ 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.