(124 days)
The catheter is intended for temporary use in electrophysiological stimulation (pacing) and/or recording of electrical potentials.
The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings. The distal electrode segment is capable of forming a 270° standard curve configuration. The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumb-slide steering control that actuates the curve. This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.
The provided document is a 510(k) summary for the Polaris X™ Unidirectional Steerable Diagnostic Catheter. This document asserts substantial equivalence to a predicate device and includes performance data related to device safety and functionality, but it does not present a study with specific acceptance criteria and reported performance for diagnostic accuracy or effectiveness in a clinical context that would typically involve a test set, ground truth established by experts, or MRMC studies.
This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, especially when the technological characteristics are very similar. The performance data provided is primarily engineering, biological, and sterility testing to ensure the device performs as intended and is safe for use.
Therefore, many of the requested categories related to diagnostic performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information presented in this 510(k) summary.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests without explicitly stating numerical acceptance criteria or detailed quantitative results in a table format. Instead, it states that "The following performance data were provided in support of the substantial equivalence determination" and later concludes that "The performance data, including biocompatibility, sterilization and design verification testing supports that the subject catheter is as safe and effective as its predicate device."
Summary of Performance Data provided:
| Test Category | Specific Tests Reported | Reported Performance (Qualitative) |
|---|---|---|
| Biocompatibility Testing | Cytotoxicity, Intracutaneous Reactivity, Pyrogen Testing, Genotoxicity (Mouse Lymphoma, Bacterial Reverse Mutation Study), Hemolysis (Direct Contact, Extract Method), Platelet and Leukocyte Count, Sensitization, Acute Systemic Toxicity, Thrombogenicity (Partial Thromboplastin Time), Complement Activation (SC5b-9) | Performed per GLP, ISO 10993-1:2018, and FDA Guidance. Implied to meet acceptable standards for externally communicating, limited contact, circulating blood contacting devices, supporting substantial equivalence and safety. |
| Sterilization Testing | Ethylene Oxide Residual Testing | Conducted to verify acceptable residual limits per ISO 10993-7. Implied to have met these limits. |
| Microbial Testing | Bacterial Endotoxin Testing | Performed per ANSI/AAMI ST72. Confirmed that endotoxin levels were not adversely affected. Implied to meet acceptable levels. |
| Microbial Testing | Bioburden Testing | Performed per ISO 11737-1. Confirmed that bioburden levels were not adversely affected. Implied to meet acceptable levels. |
| Design Verification | Reliability Cycle: Mechanical Integrity after Introduction / Withdrawal, Reliability Cycle: Mechanical Integrity after Steering Lifecycle, Twisting | Supports that the subject catheter is as safe and effective as its predicate device. This implies the device maintained mechanical integrity and functionality through these tests, satisfying product specifications (though the specific specifications are not detailed in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The reported performance data are primarily laboratory and bench testing, not clinical studies involving "test sets" in the diagnostic sense, expert interpretation, or patient data. The "test sets" would refer to the samples or units of product subjected to the engineering, biological, and sterility tests. The document does not specify the number of units tested for each specific test.
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 device is an electrode recording catheter, and the 510(k) pertains to its substantial equivalence based on safety and basic functional performance, not on direct diagnostic interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a steerable diagnostic catheter, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic "ground truth." The "ground truth" for the performance data presented would be the established scientific and engineering standards and specifications (e.g., ISO, ANSI/AAMI standards, internal product specifications).
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).