(41 days)
As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.
TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.
The provided text describes a 510(k) submission for a medical device called "TheCurve™," an intrauterine insemination catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "Select IUI®."
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state "acceptance criteria" in a quantitative sense as might be found in a performance study with defined thresholds (e.g., minimum sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to the already approved predicate.
| Feature | TheCurve™ (New Device) Performance | Select IUI® (Predicate Device) Performance | Equivalence Justification |
|---|---|---|---|
| Intended Use | Single use, sterile, disposable, flexible catheter designed for intrauterine artificial insemination. | Single use, sterile, disposable, flexible catheter designed for intrauterine artificial insemination. | Identical |
| Constituent Materials | Identical to Select IUI®. | Identical to TheCurve™. | Identical |
| Length (Effective) | 17.2 cm | 17 cm | Minor difference (1 mm shorter), not cited as a concern for effectiveness or safety. |
| Length (Overall) | 19.9 cm | 20 cm | Minor difference (1 mm shorter), not cited as a concern for effectiveness or safety. |
| ID (Inner Diameter) | 1.1 mm for effective length | 1.6 mm for effective length | Minor difference (0.5 mm smaller). The implication on performance (e.g., flow rate) is not discussed in detail but is implicitly deemed acceptable given the substantial equivalence claim. |
| OD (Outer Diameter) | 2.6 mm stepped down to 1.6 mm for distal 4.5 cm of length | 2.6 mm stepped down to 2.1 mm for distal 4.5 cm of length | Differences in distal OD are minor and related to the curvature of TheCurve™. Implicitly deemed acceptable. |
| Graduation Marks | Identical to Select IUI® (six colored markings at 5, 6, 7, 8, 9, and 10 cm from the distal tip). | Identical to TheCurve™. | Identical |
| Design | Inner polyethylene tube within an outer polypropylene sheath. Distal portion is curved. Extreme distal tip is open. | Inner polyethylene tube within an outer polypropylene sheath. Distal portion is straight. Extreme distal tip is closed with two side openings. | Differences (curved distal tip, open vs. closed distal tip) are described as improvements to ease insertion. Implicitly deemed acceptable for maintaining or improving safety and effectiveness. |
| Function | Identical to Select IUI® (channel for flow). | Identical to TheCurve™. | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not describe a formal "test set" or a study with human subjects (clinical trial) to evaluate the device's performance against specific acceptance criteria. This submission is a 510(k) for substantial equivalence based on device comparison and technical specifications, not a clinical performance study. Therefore, there's no sample size or data provenance in the context of a clinical test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. As no clinical study or performance evaluation with a "ground truth" was conducted or reported, no experts were involved in establishing such ground truth for a test set. The "truth" in this submission relies on the comparison of engineering specifications and intended use to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
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 manual medical instrument (an intrauterine insemination catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a manual medical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness of the predicate device (Select IUI®). The new device, TheCurve™, is compared against the predicate's specifications and intended use.
8. The Sample Size for the Training Set
Not applicable. Since there's no algorithm involved, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there's no algorithm involved, there is no "training set" or ground truth for it.
In summary:
This 510(k) submission relies on a "benchmarking" or "comparison" approach rather than a clinical performance study with a defined test set and acceptance criteria. The "acceptance criteria" are implicitly met if the FDA determines the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, despite some minor physical differences that are argued to either have no impact or slightly improve usability (e.g., curved tip for easier insertion). The evidence provided is primarily a detailed technical comparison of the new device with the legally marketed predicate device.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).