(24 days)
For use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.
The proposed device consists of a two-lumen catheter with proximal bifurcation and luer hubs. The device will be supplied with a removable stylette in one of the lumens that is intended to provide support and prevent kinking as the catheter is inserted through the working channel of a bronchoscope.
This 510(k) summary describes a medical device, the Bistech Dual-Lumen Catheter, submitted for clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-powered devices.
Instead, this document is an Abbreviated 510(k) for a conventional medical device. The "Safety and Performance" section explicitly states: "This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Bistech, Inc. has provided information to demonstrate conformity with the following FDA-recognized consensus standard: ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters."
This means the device's "performance" and "safety" are demonstrated by its conformity to an established consensus standard (ISO 10555-1;1999) rather than a specific clinical performance study with acceptance criteria. The clearance is based on substantial equivalence to predicate devices.
Therefore, many of the requested details, such as sample size for test sets, expert ground truth, MRMC studies, and standalone performance, are not applicable or provided in this type of submission.
Here's a breakdown of the available information, noting what is not present:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly stated as numerical performance metrics with acceptance criteria in this document. Instead, the device performance is demonstrated by its compliance with the ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters standard and its substantial equivalence to predicate devices, based on various product features.
The table {1} compares the Bistech Dual-Lumen Catheter's features to predicate devices. This comparison implicitly shows that the physical characteristics and intended use are similar, implying comparable performance.
| Product Feature | Bistech Dual-Lumen Catheter (current submission) | Predicate Devices (Average/Range) Implicit Performance |
|---|---|---|
| Outer Diameter | 1.7 mm | 1.8 mm - 2.6 mm (similar range) |
| Working Length | 100 cm | 105 cm - 150 cm (similar range) |
| # of Lumens | Two | One or Two (similar design) |
| Design | Dual-lumen catheter | Various (dual-lumen, single lumen, etc. with similar function) |
| Packaging | Tyvek/Plastic Pouch | Tyvek/Plastic Pouch (identical) |
| Sterile/Non-Sterile | Sterile | Sterile (similar, some components of predicates may be non-sterile) |
| Single Use/Reusable | Single Use | Single Use (similar, some components of predicates may be reusable) |
| Anatomical Sites of Use | Tracheobronchial tree | Tracheobronchial tree (identical) |
| Indications for Use | To deliver fluids into or withdraw fluids from the lung | Similar (e.g., aspirate tissue/cells, mini-bronchoalveolar lavage) |
Acceptance Criteria: Conformity to ISO 10555-1;1999 (Amendment 1). The document states: "Bistech, Inc. has provided information to demonstrate conformity with the following FDA-recognized consensus standard: ISO 10555-1;1999 (Amendment 1) Sterile, Single Use Intravascular Catheters." This standard sets the performance and safety benchmarks for this type of device. Specific quantitative acceptance criteria or results are not listed in this summary, as the submission relies on adherence to this recognized standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This submission relies on compliance with a consensus standard and comparison to predicate devices, not on a clinical performance study with a test set in the traditional sense for AI/ML devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. No clinical ground truth derivation is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No adjudication method is described.
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/Not provided. This is a conventional medical device (catheter), not an AI/ML device, so no MRMC study or human reader improvement analysis would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. The "ground truth" for this device's safety and effectiveness is its adherence to the ISO 10555-1;1999 standard and its substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
Not applicable/Not provided. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. No training set or ground truth for a training set is relevant to this device submission.
§ 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.