(27 days)
The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.
The provided document is a 510(k) Summary for the Enpath Medical Steerable Sheath. It describes a Special 510(k) Submission, meaning it's for a modification to a previously cleared device (K043489). Therefore, the study focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo evaluation of efficacy against acceptance criteria in the same way a novel device might.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Test results verify that the device performs per specification requirements." The "specification requirements" are not detailed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions safely and effectively | Test results verify that the device performs per specification requirements. |
| Articulation functions correctly | Functional testing of the articulation was performed and passed. |
| Deflection radius meets specifications | Deflection radius testing was performed and passed. |
| Deflection force meets specifications | Deflection force testing was performed and passed. |
| Hemostasis of valve portion meets specifications | Hemostasis of the valve portion testing was performed and passed. |
| Deflection cycle endurance meets specifications | Deflection cycle testing was performed and passed. |
| Other applicable device specifications are met | "Other testing as applicable to this device" was performed and passed. |
| Device is equivalent to the predicate device (K043489) without creating additional risk. | "Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for the test set for any of the performance tests (articulation, deflection radius, deflection force, hemostasis, deflection cycle testing, etc.). It only mentions that "The performance testing for this device included testing..."
- Data Provenance: Not explicitly stated, but given this is a U.S. FDA submission for a U.S.-based company (Enpath Medical Inc., Minneapolis, MN), it can be inferred that the testing and data likely originated from the U.S. The testing appears to be prospective as it's described as "performance testing" to "verify that the device functions."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was an engineering performance study for a medical device modification, not a study involving human interpretation of data where expert consensus would establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this was an engineering performance study.
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 Sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the device itself (not an algorithm) was performed. The document states: "The performance testing for this device included testing to verify that the device functions in a safe and effective manner." This refers to laboratory-based functional and mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing would be the established engineering and design specifications for the device's functional and mechanical properties. For example, the specified range for deflection radius, the maximum deflection force, and the number of cycles the sheath must withstand. These specifications are determined during the device's design and development phase to ensure it functions as intended and safely.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this submission. The training set for the manufacturing process (e.g., quality control samples) is not discussed here.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).