(28 days)
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
The provided 510(k) summary for the Ocelot Catheter (K123462) describes the device, its intended use, and substantial equivalence to a predicate device (original Ocelot Catheter K122380). However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, etc.
Instead, the submission focuses on non-clinical performance data which primarily demonstrate the physical and functional aspects of the catheter in comparison to its predicate. The "study" mentioned refers to this non-clinical testing.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (as reported) | Reported Device Performance (as reported) |
|---|---|---|
| Mechanical Performance | Catheter does not advance when tip is engaged in tissue (Tip penetration testing) | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Physical Characteristics | Visual and Dimensional Verification | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Functional Testing | Spiral Blade Functional Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Material/Durability | Tensile Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Surface Properties | Coating Friction Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Ease of Use/Handling | Torque Testing, Guidewire advancement, Device Advancement, Flexibility/Trackability | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Safety/Integrity | Device leak testing, Luer Leak Testing, Tip-Stall Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Simulated Use | In Vitro Simulated Use Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Shelf Life | Shelf Life Testing | Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications. |
| Clinical Performance (e.g., accuracy, sensitivity, specificity for Ocelot system's intended function of guiding wires) | NOT SPECIFIED IN K123462 SUBMISSION | NOT REPORTED IN K123462 SUBMISSION |
Crucially, the document does not list any acceptance criteria related to its clinical effectiveness in facilitating guidewire placement or the accuracy of its OCT-assisted orientation. It only states that the non-clinical testing "confirmed that the Ocelot Catheter performs according to the stated intended use."
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "non-clinical testing" and lists various tests (e.g., visual, dimensional, tensile, torque, in vitro simulated use). For these engineering tests, the "sample size" would refer to the number of catheters tested for each specific test, which is not provided.
- Data Provenance: The data is based on non-clinical (bench/lab) testing conducted by Avinger, Inc. There is no information on country of origin of the data beyond "Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063." The data is presented as retrospective as it was conducted to support a determination of substantial equivalence (i.e., after the design changes were made).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for the non-clinical tests would be defined by engineering specifications and objective measurements, not by expert consensus in the way a clinical study would use clinicians for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As this is non-clinical engineering testing, there is no mention or need for an adjudication method in the context described. Results would be compared directly to pre-determined product specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The provided 510(k) summary does not mention any MRMC comparative effectiveness study. It focuses solely on non-clinical testing for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. The Ocelot Catheter is a medical device (a physical catheter with OCT imaging capability for human-assisted guidance), not a standalone algorithm. Its intended use inherently involves human interaction (manual advancement of the catheter, interpretation of OCT images as an adjunct to fluoroscopy).
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" was based on pre-determined product specifications and external standard requirements. For example, a tensile test would have a specified breaking strength; the measurement from the test would be compared to that specification.
8. The sample size for the training set:
- Not Applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or AI model that would be trained on data. The device's design and manufacturing rely on engineering principles and quality control, not machine learning training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an algorithm, there is no corresponding ground truth for it.
§ 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).