(93 days)
The MobiCath Transseptal Needle is used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.
The MobiCath Transseptal Needles consist of a thin-walled stainless steel cannula bonded to an ergonomic handle and stopcock, and a removable stylet. The cannula is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with an introducer or catheter. The handle is integrated with a pointer to show the orientation of the curve. The two-way stopcock facilitates air aspiration, fluid infusion, blood sampling, and pressure monitoring. The stylet attaches to the proximal end of the needle assembly.
Here's an analysis of the provided text regarding the MobiCath Transseptal Needle, focusing on the acceptance criteria and the study that proves the device meets them.
This document describes a 510(k) submission for a modified medical device, specifically stating "Greatbatch Medical proposes using an alternate stopcock for the MobiCath Trasseptal Needles. The current stopcock has been discontinued by the supplier. A similar stopcock has been tested as a replacement. A few minor design changes are required for the stopcock to interface with the handle components. In addition, a few manufacturing improvements have been proposed." This means the studies are not for a novel device but to demonstrate substantial equivalence of the modified device to a previously cleared predicate device (MobiCath Transseptal Needle K111644).
Therefore, the "acceptance criteria" here are to demonstrate that the changes have not introduced new safety or efficacy issues and that the device performs equivalently to the predicate. The "study" refers to a battery of non-clinical tests.
Acceptance Criteria and Device Performance
The provided document doesn't explicitly list "acceptance criteria" with numerical thresholds in a table format for each test. Instead, it describes a series of tests performed to ensure the modified device (with a new stopcock) maintains the same performance and safety profile as the predicate device. The implied acceptance criterion for each test is that the modified device performs comparably to the predicate or within established engineering specifications for the original device.
Since specific numerical thresholds for acceptance are not provided, the "Reported Device Performance" is generally stated as "risks have been mitigated and that no new safety or efficacy issues were raised," implying successful completion of the tests.
| Acceptance Criterion Category | Specific Tests Performed | (Implied) Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Design Verification Bench | Visual & Dimensional Inspection | Device visually and dimensionally conform to specifications for the modified design, ensuring proper fit and function with handle components. | Risks mitigated, no new safety/efficacy issues raised. |
| Functional Testing (Tensile, Torque, Stopcock gauging) | Device components (stopcock, handle) withstand specified forces and exhibit expected mechanical properties (tensile strength, torque resistance, proper gauging). | Risks mitigated, no new safety/efficacy issues raised. | |
| Air and liquid leakage | No leakage of air or liquid through the stopcock or its interfaces. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stopcock separation force | Stopcock remains securely attached to the handle during normal use and within specified force limits. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stopcock resistance to override | Stopcock function (e.g., stopping flow) cannot be easily overridden unintentionally. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stopcock ease of assembly | Stopcock can be assembled easily and correctly with the handle. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stopcock stress cracking | Stopcock material does not exhibit stress cracking under specified conditions. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stylet to stopcock retention force | Stylet is retained by the stopcock with appropriate force during use. | Risks mitigated, no new safety/efficacy issues raised. | |
| Stylet insertion through needle | Stylet can be inserted smoothly and correctly through the needle. | Risks mitigated, no new safety/efficacy issues raised. | |
| Biocompatibility Testing | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Rabbit Pyrogenicity, Hemocompatibility (Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte Counts, Complement Activation C3a and SC5b-9) | Materials are biocompatible, non-toxic, non-irritating, non-sensitizing, non-pyrogenic, and do not cause adverse hematological reactions. | Risks mitigated, no new safety/efficacy issues raised. |
| Package Distribution | Packaging protects the device during distribution. | Risks mitigated, no new safety/efficacy issues raised. | |
| Shelf Life | Device maintains its safety and performance characteristics for its specified shelf life. | Risks mitigated, no new safety/efficacy issues raised. | |
| Sterilization Rationale | Sterilization method is effective and validated. | Risks mitigated, no new safety/efficacy issues raised. | |
| EtO Residual Testing | Ethylene Oxide (EtO) residuals are within acceptable limits after sterilization. | Risks mitigated, no new safety/efficacy issues raised. |
Study Details
-
Sample sizes used for the test set and data provenance:
- The document does not specify sample sizes for any of the non-clinical tests.
- The data provenance is not explicitly stated in terms of country of origin, but it is clear these are retrospective tests conducted by Greatbatch Medical to support the 510(k) submission for a device modification. They are lab-based tests, not clinical studies involving patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable here. These are non-clinical engineering and biological tests conducted in a laboratory setting, not studies involving human interpretation of medical data (like radiology images). "Ground truth" in this context would refer to established engineering specifications or industry standards, which are not set by human experts in the sense implied by the question.
-
Adjudication method for the test set:
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies where multiple readers interpret complex data. These are objective non-clinical tests with predefined pass/fail criteria.
-
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:
- This is not applicable. This submission is for a physical medical device (transseptal needle) and does not involve AI, image interpretation, or human readers in an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an algorithmic or AI-based device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests performed, the "ground truth" refers to predefined engineering specifications, material properties standards, and biocompatibility standards. For example, for "Air and liquid leakage," the ground truth is an established standard for permissible leakage, or zero leakage. For "Tensile" testing, it would be a specified tensile strength range.
-
The sample size for the training set:
- This is not applicable. This is not a machine learning or AI device that requires a training set.
-
How the ground truth for the training set was established:
- This is not applicable. As above, there is no training set for this type of device submission.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.