(48 days)
The Blowfish™ Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or bronchial delivery into selected and sub-selected regions of the airway tree.
The Blowfish™ Transbronchial Micro-Infusion Catheter is a bronchoscope guided, single-operator, catheter that consists of a microscopic, tapered stainless steel infusion port, a semi-rigid/semi-elastic polymer balloon, a composite metal and polymer catheter shaft, a pressure relief valve and a proximal hub with standard luer attachment fittings. The device is designed to be advanced through a bronchoscope to a target location in the tracheobronchial three and inflated to move the micro-infusion port into the airway wall to deliver therapeutics to the bronchial tissue including the bronchial adventitia.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Blowfish Transbronchial Micro-Infusion Catheter:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a direct description of acceptance criteria for a new AI/software device. Therefore, many of the requested categories for AI/software device evaluation (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable or explicitly stated for this type of medical device submission.
The "acceptance criteria" discussed in this document refer to the device meeting its mechanical performance requirements and biocompatibility standards for demonstrating substantial equivalence to a predicate device. It's a different type of evaluation than what's typically performed for a diagnostic AI algorithm.
Acceptance Criteria and Device Performance for Blowfish Transbronchial Micro-Infusion Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Source of Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Mechanical & Fluid Delivery Performance | "Product specification" | "All tests met the pre-determined acceptance criteria." (Specific details of the criteria and corresponding performance values are not provided in this summary.) |
| Packaging & Labeling Testing | (Implied regulatory requirements) | "All tests met the pre-determined acceptance criteria." (Specific details not provided.) |
| Shelf-Life Testing | (Implied regulatory requirements) | "All tests met the pre-determined acceptance criteria." (Specific details not provided.) |
| Biocompatibility | ISO 10993-1: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity | "was previously conducted with a legally marketed device (K062752)" and for the Blowfish, "materials included... were tested and demonstrated to be biocompatible and safe." (Specific test outcomes not detailed, but conformance to standard is asserted.) |
| In-vivo Safety (Porcine Model) | (Implied safety endpoints) | "Test results indicated that the catheter's materials, mode of action and procedure... are safe and do not raise different questions of safety and effectiveness compared to the predicate device." (No specific quantitative performance metrics provided; general statement of safety.) |
| Sterility | SAL 10-6 | Sterile (SAL 10-6) |
| Single Use | (Design specification) | Yes |
| Target Diameter (Balloon) | (Design specification) | 6.0 mm to 16.0 mm |
| Max Inflation Pressure (Balloon) | (Design specification) | 2 atm controlled by pressure relief valve |
| Bronchoscope Channel ID | (Compatibility specification) | 2.8 mm |
| Length | (Design specification) | Up to 145 cm |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the summary. The performance data section refers generally to "bench, in vitro and in vivo animal studies" without providing specific subject counts for each test.
- Data Provenance:
- Bench (laboratory, in vitro) studies.
- In vivo animal studies using a porcine model.
- No mention of human clinical data or geographical origin of data for these specific tests. The biocompatibility data references a previous 510(k) (K062752) for another device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a catheter, not a diagnostic algorithm. Therefore, there is no "ground truth" established by experts in the context of diagnostic interpretation. The evaluation is focused on engineering performance, material safety, and in-vivo physiological effects in an animal model.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, no diagnostic "ground truth" 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 is a hardware device, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a hardware device, not an AI or diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Reinterpreted: The "ground truth" for this device's evaluation is primarily established by:
- Engineering specifications: For mechanical and fluid delivery performance (e.g., meeting specific pressure, diameter, length requirements).
- Regulatory standards: For biocompatibility (ISO 10993-1).
- Physiological safety: Observed outcomes in the porcine animal model to ensure the device's interaction with tissue is safe and does not raise new safety concerns compared to the predicate.
8. The sample size for the training set:
- Not Applicable. This device uses traditional engineering and biological testing, not machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. (See #8)
§ 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.