(212 days)
The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.
The Park Blade Septostomy Catheter is a radiopaque polyethylene catheter with a distal tip section made of a stainless-steel cannula and a proximal end section consisting of a pin vise, a gasket, and a Y sidearm adapter. The distal stainless-steel cannula contains a stainless-steel blade that is linked to a lever, which allows the distal end to form a triangle. The Park Blade Septostomy Catheter is manufactured in 5.7 or 7.3 French sizes. The catheter working length measures either 65 or 85 centimeters from the distal tip to the distal end of the shrink tube. The blade lengths for the 5.7 French catheters are either 9.4 or 13.4 millimeters; for the 7.3 French size catheter, the blade measures 20.0 millimeters.
The provided text is a 510(k) summary for the Park Blade Septostomy Catheter. It outlines the device description, indications for use, comparison to a predicate device, and test data conducted to demonstrate substantial equivalence.
However, this submission is for a traditional medical device (catheter) and does not involve Artificial Intelligence (AI) or machine learning (ML). Therefore, many of the requested categories related to AI/ML device performance, ground truth, expert review, training sets, and MRMC studies are not applicable.
Below, I will answer the relevant questions based on the provided text, and explicitly state "Not Applicable" for questions related to AI/ML.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This submission is for a medical catheter (Park Blade Septostomy Catheter), which is a physical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the "acceptance criteria" discussed are related to the physical and material properties of the catheter, and the "study" refers to the engineering and biocompatibility tests conducted on the device.
1. A table of acceptance criteria and the reported device performance
The document states that pre-determined acceptance criteria were met for all tests. However, the specific quantitative acceptance criteria for each test are not detailed in this summary. The summary only reports the outcome that the criteria were satisfied.
| Test Performed | Reported Device Performance |
|---|---|
| Biocompatibility Testing | The pre-determined acceptance criteria were met. |
| Radiopacity Testing | The pre-determined acceptance criteria were met. |
| Tensile Testing | The pre-determined acceptance criteria were met. |
| Corrosion Testing | Revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met. |
| Dimensional and Blade Activation Verification | The pre-determined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the physical and material tests (Biocompatibility, Radiopacity, Tensile, Corrosion, Dimensional, and Blade Activation Verification). It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these tests are typically conducted in a laboratory setting.
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. This is a physical device; "ground truth" and "experts" in the context of diagnostic interpretation are not relevant here. The tests are based on engineering standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This concept is relevant for interpreting ambiguous results, usually in diagnostic imaging or clinical trials with subjective endpoints. The tests performed are objective physical and material property evaluations.
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 physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these types of tests are the specifications and requirements defined by the relevant ISO, ASTM, and BS EN standards (e.g., ISO 10993-1:2009 for biocompatibility, ASTM F640-12 and BS EN ISO 10555-1 for radiopacity, BS EN ISO 10555-1 for tensile and corrosion, and design input specifications for dimensional/blade activation). These are established engineering benchmarks.
8. The sample size for the training set
Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable. This is a physical device; there is no "training set" or "ground truth" establishment in the context of machine learning.
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).