(112 days)
The MobiCath™ Transseptal Needle is used to create the primary puncture in the inter-atrial 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 Needle consists of a thin-walled stainless steel cannula which is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with a transseptal catheter or introducer. The proximal end of the needle is bonded to an ergonomic handle with an integrated pointer to show the orientation of the curve section and a two-way stopcock to facilitate air aspiration, fluid infusion, blood sampling, and pressure monitoring. The Transseptal Needle includes a stylet with an over-molded hub designed to attach to the proximal end of the needle assembly.
This is a Premarket Notification (510(k)) for the MobiCath Transseptal Needle, a medical device for creating punctures in the inter-atrial septum. The provided document describes the device, its indications for use, comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, the acceptance criteria are implicit in the performance of the predicate devices and the successful completion of a battery of non-clinical tests. The stated objective is to demonstrate that the device "performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."
The reported device performance is that it "passed all verification specification criteria." This indicates that the device met internal design and functional requirements, which were presumably benchmarked against the predicate devices.
| Acceptance Criterion Type | Specific Criteria Mentioned | Reported Device Performance |
|---|---|---|
| Safety & Efficacy | Device performs as intended and does not raise new questions of safety or efficacy compared to predicate devices (K072278 and K011727). | "Test results confirm the device performs as intended without raising additional questions of safety and efficacy when compared to the predicates." |
| Sterilization | Compliance with ISO 11135-1 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices). | "Sterilization Testing per ISO 11135-1." (Implies successful completion) |
| Shelf Life | Demonstrated appropriate shelf life of the device. | "Shelf Life" (Implies successful completion, no specific duration detailed in this summary) |
| Biocompatibility | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) through tests for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Rabbit Pyrogen, Hemocompatibility (Hemolysis Test, Partial Thromboplastin Time, Platelet and Leukocyte Counts, Complement Activation C3a and SC 5b-9, Thrombosis). | "Biocompatibility per ISO 10993-1" and lists all the specific tests. (Implies successful completion of all listed tests) |
| Performance Bench | Meeting "verification specification criteria" for Visual, Dimensional, and Functional aspects. Functional tests included: Tensile strength, Torque, Resistance to breakage, Stopcock separation force, Hub to stopcock retention force, Stopcock gauging, Leakage, Stopcock ease of assembly, Stopcock stress cracking, Needle and stylet insertion through dilator. | "Performance Bench" and lists all the specific tests. "The MobiCath™ Transseptal Needle passed all verification specification criteria for dimensional, functional, packaging, sterilization, biocompatibility and shelf life tests." (Implies successful completion of all listed tests) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each bench test conducted. It states "Performance (bench) testing... were performed." For sterilization, shelf life, and biocompatibility, standard protocols according to the cited ISO standards would have been followed, which inherently involve specific sample sizes. However, these are not quantified in the summary.
- Data Provenance: The testing described is pre-clinical bench testing. There is no mention of human subject data, animal data (beyond specific biocompatibility tests like "Rabbit Pyrogen"), or retrospective/prospective clinical data for the performance evaluation. It's all laboratory-based, controlled testing of the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this 510(k) submission. This is a pre-clinical performance study of a physical medical device, not an AI or diagnostic imaging device that requires expert-established ground truth for a test set. The "ground truth" for the performance tests would be the established engineering specifications and industry standards (e.g., ISO, internal design requirements) that the device must meet.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., image interpretation) to resolve discrepancies in ground truth establishment. The tests performed here are objective bench tests with pass/fail criteria based on specifications.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools or image analysis, which this device is not. The MobiCath Transseptal Needle is a physical surgical tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The device is a physical, manually operated transseptal needle and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for the performance evaluation in this 510(k) is based on engineering specifications, industry standards (e.g., ISO 11135-1, ISO 10993-1), and the performance characteristics of the predicate devices. The device had to pass "verification specification criteria" in various bench tests. This is a form of "established scientific principles and objective measurements" as ground truth.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set.
§ 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.